Circular 32/2023/TT-BYT guiding the Law on Medical Examination and Treatment issued by the Minister of Health

 

CIRCULAR

DETAILING CERTAIN PROVISIONS OF THE MEDICAL EXAMINATION AND TREATMENT LAW

Pursuant to the Law on Health Examination and Treatment No. 15/2023/QH15 dated January 9, 2023;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the request of the Director of the Department of Medical Examination and Treatment and the Director of the Department of Science, Technology and Training, and the Head of the Cadre Organization Department;

The Minister of Health issues this Circular detailing certain provisions of the Medical Examination and Treatment Law.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates on:

1. Continuous medical knowledge updating in medical examination and treatment as stipulated in Clause 14, Article 2 and Clause 4, Article 22 of the Medical Examination and Treatment Law.

2. Scope of practice for medical examination and treatment for specialized positions as stipulated in Clause 3, Article 26 of the Medical Examination and Treatment Law.

3. Model medical examination and treatment practice permit as stipulated in Clause 5, Article 27 of the Medical Examination and Treatment Law.

4. Recognition of quality standards for medical examination and treatment facilities established by domestic organizations or foreign organizations as stipulated in Point d, Clause 1 and Clause 4, Article 57 of the Medical Examination and Treatment Law.

5. Medical records and summary medical records as stipulated in Clause 1, Article 69 of the Medical Examination and Treatment Law.

6. On-call duty for medical examination and treatment as stipulated in Clause 3, Article 70 of the Medical Examination and Treatment Law.

7. Standards and procedures for health check-ups as stipulated in Clause 2, Article 83 of the Medical Examination and Treatment Law.

8. Good Clinical Practice (GCP) for testing new techniques, methods, or medical equipment as stipulated in Point d, Clause 4, Article 99 of the Medical Examination and Treatment Law.

9. Regulations on the organization and operation of the Professional Council and the procedure and formalities for resolving disputes when medical accidents occur as stipulated in Clause 6, Article 101 of the Medical Examination and Treatment Law.

10. Mobilization, dispatching, and assignment of tasks for individuals participating in medical examination and treatment in cases of natural disasters, catastrophes, infectious diseases classified as Group A, or emergency situations as stipulated in Clause 4, Article 115 of the Medical Examination and Treatment Law.

Article 2. Interpretation of Terms

1. Continuous medical knowledge updating bases for medical examination and treatment are medical examination and treatment facilities, educational institutions involved in training healthcare personnel, and professional social organizations related to medical examination and treatment that meet the requirements for organizing continuous medical knowledge updating as prescribed in this Circular.

2. Credit hours in continuous medical knowledge updating are units of time for practitioners participating in any form of continuous medical knowledge updating with conversion formulas as prescribed in Appendix I attached hereto.

3. Clinical trials of new techniques, methods, and medical equipment are scientific research activities conducted on voluntary subjects to investigate or determine the safety and efficacy of new techniques, methods, and medical equipment in clinical settings; identify and detect adverse reactions caused by new techniques, methods, or medical equipment; assess the ease of use of medical equipment for doctors and healthcare staff; evaluate the performance of in vitro diagnostic medical equipment.

4. Good Clinical Practice (GCP) for testing new techniques, methods, or medical equipment in clinical settings is a set of principles and standards for designing, organizing, implementing, monitoring, inspecting, recording, analyzing, and reporting clinical trials of new techniques, methods, and medical equipment to ensure the reliability and accuracy of research data and reports, protect the rights, safety, and confidentiality of research subjects.

5. Investigator's Brochure (IB) for products is a document containing general information about new techniques, methods, and medical equipment under clinical research; preclinical research documents and previous phase clinical trial research documents (if any).

6. Case Report Form (CRF) for research data collection or Research Medical Record is a paper or electronic tool designed to collect research data from participants in clinical trials of new techniques, methods, and medical equipment.

7. ICD (International Classification of Diseases) is the international classification of diseases.

Chapter II

CONTINUOUS MEDICAL KNOWLEDGE UPDATING FOR PRACTITIONERS IN MEDICAL EXAMINATION AND TREATMENT

Article 3. Continuous Medical Knowledge Update Period

1. Medical practitioners have the obligation to participate in continuous medical knowledge update for a minimum of 120 credit hours within five consecutive years (one credit hour for short-term training courses equivalent to one class period).

2. Medical practitioners participating in any of the forms of continuous medical knowledge update as stipulated in Articles 4, 5, 6, and 7 of this Circular, after converting to credit hours, will be combined to calculate the total time of continuous medical knowledge update.

Article 4. Continuous Medical Knowledge Update through Participation in Short-Term Training Courses, Refresher Courses, Conferences, and Seminars on Medicine Relevant to Scope of Practice

1. Continuous Medical Knowledge Update through Participation in Short-Term Training Courses and Refresher Courses:

a) Short-term training courses and refresher courses on medical examination and treatment are training programs with curricula and materials developed, reviewed, and issued according to the provisions of this Circular;

b) Short-term training courses and refresher courses can be organized in person or in a hybrid format combining online and offline methods, suitable for the specific content of each course;

c) The organizing entity is a medical examination and treatment facility, an educational institution involved in health workforce training, or a social-professional organization related to medical examination and treatment;

d) The entity providing continuous medical knowledge update must develop plans for organizing short-term training courses and refresher courses and publicly disclose them on their website before implementation;

đ) The continuous medical knowledge update program must align with the approved scope of professional activities for the entity providing continuous medical knowledge update or match the level of education in medical examination and treatment fields of the educational institution assigned the training task. The continuous medical knowledge update program should be developed following the guidelines set out in Appendix III attached to this Circular and regularly reviewed and updated to ensure scientific accuracy and practical relevance;

e) Continuous medical knowledge update materials must be based on the issued curriculum and follow the guidelines set out in Appendix III attached to this Circular. These materials need to be regularly reviewed and updated to ensure scientific accuracy and practical relevance;

g) The entity providing continuous medical knowledge update may use programs and materials from other entities that have been issued, provided they agree in writing;

h) The head of the entity providing continuous medical knowledge update selects and arranges sufficient instructors to meet the requirements of the training program;

i) Certificate for participation in short-term training courses and refresher courses: After completing a short-term training course or refresher course, the practitioner will be issued a certificate according to Appendix II attached to this Circular.

2. Continuous Medical Knowledge Update through Participation in Conferences and Seminars:

a) Medical conferences and seminars are events organized by entities providing continuous medical knowledge update in medical examination and treatment, with content related to medical examination and treatment;

b) The main organizer: Must have a scope of professional activities approved by the competent authority that matches the conference or seminar content;

c) Topic and Content: Must align with the scope of professional activities in medical examination and treatment of the main organizer;

d) Speaker: Must have a scope of practice compatible with the presentation content and the theme of the conference or seminar;

đ) Organizing Method: In person or online;

e) Certificate for participation in conferences and seminars: Practitioners attending conferences and seminars will be issued a certificate by the main organizer according to Appendix II attached to this Circular.

Article 5. Continuous updating of medical knowledge through participation in the compilation of textbooks, teaching materials, and specialized materials on diagnosis and treatment.

Clause 1. Compiling textbooks, teaching materials, and specialized materials on diagnosis and treatment involves participating in specialized committees or groups responsible for drafting such materials, which include content on diagnosis and treatment, and are officially issued by the head of the organizing unit.

Clause 2. Medical practitioners who lead or participate in specialized committees or groups responsible for drafting textbooks, teaching materials, and specialized materials on diagnosis and treatment within their scope of practice, and which have been officially issued by the head of the organizing unit.

Clause 3. Certification for participation in the compilation of textbooks, teaching materials, and specialized materials: Medical practitioners who lead or participate in the compilation of such materials will have their credit hours calculated and be issued a certificate according to Appendix II attached to this Circular by the head of the organizing unit.

Article 6. Continuous updating of medical knowledge through conducting scientific research and teaching in the field of medicine within the scope of practice.

Clause 1. Continuous updating of medical knowledge through conducting scientific research within the scope of practice:

Point a. Medical practitioners who lead or participate in scientific and technological tasks at the institutional, ministerial, provincial, or national levels, or technical improvement initiatives, or write scientific articles domestically and internationally with content related to diagnosis and treatment, consistent with their scope of practice. These scientific and technological tasks must have acceptance decisions, technical improvement initiatives must be recognized, and scientific articles must be published in domestic and international scientific journals, newsletters, and special issues.

Point b. Certification for conducting scientific research: Medical practitioners who complete scientific and technological tasks at various levels, technical improvement initiatives, or write scientific articles will have their credit hours calculated and be issued a certificate according to Appendix II attached to this Circular by the head of the organizing unit for these scientific and technological tasks or technical improvement initiatives.

Clause 2. Continuous updating of medical knowledge through teaching in the field of medicine within the scope of practice:

Point a. Teaching in the field of medicine involves imparting knowledge, skills, and attitudes in diagnosis and treatment within the practitioner's professional scope.

Point b. Medical practitioners assigned or invited to teach in training programs leading to diplomas or certificates in health-related fields that align with their scope of practice in diagnosis and treatment.

Point c. Certification for teaching in the field of medicine: Medical practitioners involved in teaching within their scope of practice will have their credit hours calculated based on evidence of their teaching activities and be issued a certificate according to Appendix II attached to this Circular by the head of the organizing unit.

Article 7. Continuous updating of medical knowledge through self-updating of medical knowledge and other forms.

Clause 1. Self-updating of medical knowledge is the process of independently researching and studying medical knowledge and skills relevant to the practitioner's professional scope.

Clause 2. Forms of self-updating of medical knowledge and other forms include:

Point a. Medical practitioners participating in guiding dissertations and theses that align with their scope of practice, where the dissertations and theses they guide have been approved by the university-level dissertation evaluation council.

Point b. Medical practitioners participating in dissertation and thesis evaluation councils, scientific and technological task acceptance councils at various levels, specialized program and training material review councils related to diagnosis and treatment within their scope of practice, appraisal councils, and professional error review councils.

Point c. Medical practitioners participating in professional activities related to diagnosis and treatment within their scope of practice, including direct or indirect case consultations and case analysis.

Point d. Participating in domestic and international diploma training programs (excluding extended study periods) that align with their scope of practice in diagnosis and treatment.

Point e. Participating in certification training programs: basic specialty, deep specialty, professional techniques, and technology transfer that align with their scope of practice in diagnosis and treatment.

Clause 3. Certification for self-updating of medical knowledge and other forms: Medical practitioners who engage in self-updating of medical knowledge and other forms will be issued a certificate by the head of the organizing unit or the directly managing authority according to Appendix II attached to this Circular.

Article 8. Conversion to Credit Hours and Certificates for Continuous Medical Knowledge Updates

1. The conversion of continuous medical knowledge update activities to credit hours shall be carried out according to Appendix I attached hereto.

2. For continuous medical knowledge updates organized by foreign entities for healthcare practitioners: The confirmation of participation time in continuous medical knowledge updates shall be calculated in credit hours and certificates issued by the head of the entity directly managing the practitioner according to Appendix II attached hereto.

Article 9. Responsibilities of Continuous Medical Knowledge Update Entities

1. To create conditions for healthcare practitioners to continuously update their medical knowledge; monitor, manage, confirm, and calculate credit hours for practitioners participating in continuous medical knowledge updates organized by the entity.

2. To assign staff responsible for managing the continuous medical knowledge update activities of the entity.

3. To organize continuous medical knowledge update activities in accordance with this Circular and bear responsibility for the quality of continuous medical knowledge updates conducted by the entity.

4. To manage and store records, programs, and materials of short-term training courses, continuing education sessions, conference records, and continuous medical knowledge update activities of the entity; manage the confirmation process for practitioners who have completed continuous medical knowledge updates in accordance with the provisions of this Circular.

5. For entities that conduct continuous medical knowledge updates through organizing short-term training and continuing education courses: Prior to organizing such training and education, they are responsible for sending notifications according to Appendix IV attached hereto to the Ministry of Health (Department of Science, Technology, and Training) if the entity falls under the jurisdiction of the Ministry of Health, or send notifications to both the Ministry of Health and the Provincial Health Department if the entity falls under the jurisdiction of the Provincial Health Department.

Chapter III

SCOPE OF PRACTICE FOR HEALTHCARE PRACTITIONERS AND SAMPLE LICENSES

Article 10. Principles for Determining the Scope of Practice for Healthcare Practitioners

1. The determination of the scope of practice for healthcare practitioners must be consistent with the relevant medical diplomas and certificates obtained or recognized in Vietnam; consistent with the capability to perform examination, treatment activities, including specialized methods and techniques of the practitioner in the registered specialty.

2. The scope of practice for healthcare practitioners includes conducting examinations, treatments, ordering diagnostic procedures, performing examination, treatment methods, specialized technical procedures, prescribing medications, ordering care and nutrition regimens, evaluating examination and treatment outcomes, providing health counseling and education to patients in accordance with their professional titles and the regulations stipulated by the Minister of Health in Article 11 of this Circular corresponding to each title.

3. Ensuring the quality of examination and treatment services and patient safety.

4. Consistent with practical conditions, especially at units with specific characteristics, various levels of technical expertise in examinations and treatments, located in economically and socially disadvantaged areas.

5. Not discriminating against healthcare practitioners working at different levels of technical expertise in examinations and treatments and the duration of their examination and treatment practices.

Article 11. Scope of Practice for Practitioners

1. Medical Doctor: The scope of practice for examining and treating diseases is specified in Appendix V attached to this Circular.

2. Traditional Medicine Doctor: The scope of practice for examining and treating diseases is specified in Appendix VI attached to this Circular.

3. Preventive Medicine Doctor: The scope of practice for examining and treating diseases is specified in Appendix VII attached to this Circular.

4. Dental Doctor: The scope of practice for examining and treating diseases is specified in Appendix VIII attached to this Circular.

5. Specialist Doctor:

a) Intensive Care Specialist Doctor: The scope of practice for examining and treating diseases is specified in Appendices V and IX, Internal Medicine and Emergency Care sections, attached to this Circular;

b) Nutrition Specialist Doctor: The scope of practice for examining and treating diseases is specified in Appendices V and XV attached to this Circular;

c) Other Specialist Doctors: The scope of practice for examining and treating diseases is specified in Appendices V and IX according to their specialty attached to this Circular.

6. Scope of practice for practitioners with the professional title of Medical Assistant:

a) General Medical Assistant: The scope of practice for examining and treating diseases is specified in Appendix X attached to this Circular (including initial first aid techniques, general examination and treatment according to Circular Jointly Issued No. 10/2015/TTLT-BYT-BNV dated May 27, 2015 by the Ministry of Health and the Ministry of Home Affairs on job code and qualification standards for medical doctors, preventive medicine doctors, and medical assistants);

b) Traditional Medicine Medical Assistant: The scope of practice for examining and treating diseases is specified in Appendix XI attached to this Circular.

7. Scope of practice for practitioners with the professional title of Nurse is specified in Appendix XII attached to this Circular.

8. Scope of practice for practitioners with the professional title of Midwife is specified in Appendix XIII attached to this Circular.

9. Scope of practice for practitioners with the professional title of Medical Technician is specified in Appendix XIV attached to this Circular.

10. Scope of practice for practitioners with the professional title of Clinical Dietitian is specified in Appendix XV attached to this Circular.

11. Scope of practice for practitioners with the professional title of Clinical Psychologist is specified in Appendix XVI attached to this Circular and providing continuous and comprehensive care services regarding cognition, behavior, emotions, and social psychology for individuals, groups, and families, including assessing mental disorders, prescribing, developing, and implementing psychological interventions at healthcare facilities.

12. Scope of practice for practitioners with the professional title of Out-of-Hospital Emergency Responder is specified in Appendix XVII attached to this Circular.

13. Scope of practice for practitioners with the professional title of Traditional Medicine Practitioner is allowed to examine and treat diseases using traditional medicine methods and techniques and the technical list specified in Appendix XVIII attached to this Circular.

14. Scope of practice for those with family herbal remedies:

a) Those with family herbal remedies are allowed to examine and use family herbal remedies certified by the competent authority to treat diseases or conditions;

b) Family herbal remedies used for treatment must be accurate in components, dosage form, indications, dosage, and usage;

c) Multiple family herbal remedies certified by the competent authority can be used to treat different diseases or conditions in the same patient;

d) Those who have both family herbal remedies and family treatment methods can simultaneously apply them to the same patient at the same time;

e) They are not permitted to prescribe and use chemical drugs, medicinal herbs, and modern medical methods and techniques for examining and treating diseases outside the scope of practice for family herbal remedies.

15. Scope of practice for those with family treatment methods:

a) Those with family treatment methods are allowed to examine and use family treatment methods certified by the competent authority to treat diseases or conditions;

b) Family treatment methods used for treatment must comply with the procedures and diseases or conditions approved by the competent authority;

c) Multiple family treatment methods can be combined with family herbal remedies to treat different diseases or conditions in the same patient;

d) They are not permitted to use modern medical methods and techniques for examining and treating diseases outside the scope of practice for family treatment methods.

Article 12. Model of the Practice Permit for Medical Examination and Treatment

The Ministry of Health, Provincial Health Departments, the Ministry of National Defense, and the Ministry of Public Security shall issue operation permits according to the model prescribed in Appendix XIX attached hereto.

Chapter IV

RECOGNITION OF QUALITY MANAGEMENT STANDARDS FOR MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 13. Recognition of international standards and quality management standards for medical examination and treatment facilities

1. Recognize international standards and quality management standards for medical examination and treatment facilities that have been recognized by the International Society for Quality in Healthcare (ISQua).

2. The Department of Medical Examination and Treatment shall review and announce on the Ministry of Health's Electronic Portal, the Department of Medical Examination and Treatment's Electronic Information Page, and the system managing medical examination and treatment activities.

Article 14. Criteria for recognizing quality management standards for medical examination and treatment facilities not covered under Article 13 of this Circular

1. General criteria:

a) Standards must specify the application period and evaluation methods for the standards;

b) Standards must stipulate that quality certification is a voluntary activity of medical examination and treatment facilities;

c) Standards must ensure scientific and effective quality management for each service area of medical examination and treatment;

d) Standards must ensure comprehensive assessment of quality characteristics: safety, effectiveness, timeliness, fairness, patient-centeredness, and healthcare worker orientation;

đ) Standards must include criteria and indicators ensuring a full assessment of the three quality components: input, process, and outcome.

2. Specific criteria are defined in Model No. 1 of Appendix XX attached hereto.

Article 15. Documents for Requesting Recognition of Quality Management Standards for Medical Examination and Treatment Facilities

1. A request form for recognition of quality management standards for medical examination and treatment facilities according to the model specified in Model No. 02 of Appendix XX attached hereto.

2. A complete copy of the quality management standard being requested for recognition.

3. A certified copy of the Certificate of Registration for Operation of Evaluation and Certification of Medical Examination and Treatment Facilities issued to the Quality Certification Organization in accordance with Articles 76 and 77 of Decree No. 96/2023/NĐ-CP dated December 30, 2023 of the Government detailing certain provisions of the Law on Medical Examination and Treatment (hereinafter referred to as Decree No. 96/2023/NĐ-CP).

4. A certified copy of the Decision on Establishment, Business Registration Certificate, or Investment Certificate of the Quality Certification Organization.

5. Documentation proving that the standard has been tested at medical examination and treatment facilities in Vietnam including: reports on applying the standard; summaries of opinions from managers of medical examination and treatment facilities and experts in the field of quality management.

6. A response confirming compliance with specific recognition criteria for quality management standards for medical examination and treatment facilities according to the model specified in Model No. 1 of Appendix XX attached hereto.

Article 16. Procedures for Recognizing Quality Management Standards for Medical Examination and Treatment Facilities

1. The Quality Certification Organization submits one set of documents as prescribed in Article 15 of this Circular to the Ministry of Health (Department of Medical Examination and Treatment).

2. Establish the Appraisal Board:

a) The Appraisal Board is established by the Minister of Health's Decision approving its establishment, which includes: - The leader of the Ministry of Health as Chairman of the Board; - The leader of the Department of Medical Examination and Treatment as Vice-Chairman in charge, the leader of the Legal Affairs Department as Vice-Chairman; - Leaders of some Departments, Bureaus, Institutes of the Ministry of Health, some quality management experts, representatives of related Ministries, sectors, organizations, associations invited to participate as members according to the specialty fields of the proposed standards.

b) The Secretariat assists the Board, headed by the Director of the Quality Management Division of the Department of Medical Examination and Treatment as Secretary-General and other relevant members.

3. Appraisal Process:

a) The Secretariat reviews and checks the completeness and validity of the documents. If the documents are complete and valid, the Secretariat is responsible for comparing the quality management standards with the recognition criteria specified in Article 14 of this Circular and preparing an appraisal report to submit to the Board;

b) The Board convenes to appraise, reach a conclusion, and approve the minutes;

c) Within twenty days from the date of receiving complete and valid documents recorded on the Receipt Form according to Model No. 03 of Appendix XX attached hereto, based on the Board's conclusions: - In case the Board agrees to recognize the standard, the Department of Medical Examination and Treatment will submit a Decision recognizing the standard of the Quality Certification Organization according to Model No. 04 in Appendix XX attached hereto to the Minister of Health for issuance; - In case the Board does not agree to recognize the standard, within five working days from the date of the Board's conclusion, the Department of Medical Examination and Treatment will notify the Quality Certification Organization in writing that submitted the request and clearly state the reasons.

d) The Decision recognizing the standard of the Quality Certification Organization will be announced on the Department of Medical Examination and Treatment's Electronic Information Page within five working days from the date of issuing the Recognition Decision.

Chapter V

GOOD PRACTICE FOR TESTING NEW TECHNOLOGIES, METHODS OR MEDICAL DEVICES ON PATIENTS

Section 1

GENERAL PROVISIONS ON GOOD PRACTICE FOR TESTING NEW TECHNOLOGIES, METHODS OR MEDICAL DEVICES ON PATIENTS

Article 17. Principles and Standards for Good Clinical Practice (GCP) in Testing New Techniques, Methods, or Medical Devices

The principles and standards for Good Clinical Practice (GCP) in testing new techniques, methods, or medical devices are established in Appendix XXI attached to this Circular, based on guidance from ICH and WHO.

Article 18. Circumstances for Evaluating and Inspecting Compliance with Good Clinical Practice (GCP) in Testing New Techniques, Methods, or Medical Devices

1. Initial Evaluation: Conducted when a clinical trial site implements new technique, method, or medical device testing activities.

2. Periodic Evaluation: Carried out to maintain compliance with GCP, conducted every three years from the date of issuance of the certificate of compliance with GCP (excluding any unscheduled inspections).

3. Unscheduled Evaluation of Compliance with GCP is carried out according to the provisions of Article 27 of this Circular.

4. Inspection of Compliance with GCP: The Ministry of Health and Provincial Health Departments shall conduct inspections of compliance with GCP based on state management requirements, or integrate such inspections into annual professional activity inspection plans or unscheduled evaluations of compliance with GCP for clinical trial sites under their jurisdiction.

Article 19. Levels of Compliance with Good Clinical Practice (GCP) in Testing New Techniques, Methods, or Medical Devices

1. Level 1: A clinical trial site complies with GCP without any necessary corrections or improvements.

2. Level 2: A clinical trial site requires corrections or improvements to comply with GCP where such corrections or improvements do not affect the accuracy and integrity of research data and the safety and health of participants in new technique, method, or medical device trials.

3. Level 3: A clinical trial site does not comply with GCP in the following cases:

a) There are discrepancies with GCP standards that may affect the accuracy and integrity of research data and/or the health and safety of participants in new technique, method, or medical device trials;

b) Fraud, falsification, or alteration of data, records, and documents.

Section 2

INITIAL EVALUATION OF COMPLIANCE WITH GOOD CLINICAL PRACTICE (GCP) IN TESTING NEW TECHNIQUES, METHODS, OR MEDICAL DEVICES

Article 20. Documentation for Requesting Initial Evaluation of Compliance with Good Clinical Practice (GCP) in Testing New Techniques, Methods, or Medical Devices

1. Application for evaluation of compliance with GCP according to Form No. 01 stipulated in Appendix XXIII attached to this Circular.

2. Declaration of general information about the clinical trial site; physical facilities, list of medical devices; list of personnel meeting conditions for evaluation of compliance with GCP; standard operating procedures (SOPs), quality management systems for clinical trials, and supporting documents verifying these declarations. Detailed documentation preparation follows the guidelines in Appendix XXII attached to this Circular.

3. Copy of the operating license for a clinical trial site that is a healthcare facility; copy of the establishment decision or business registration certificate accompanied by a copy of the scientific and technological activity operation certificate for a clinical trial site that is a scientific and technological organization.

Article 21. Procedure for receiving files and evaluating compliance with Good Clinical Practice for testing new techniques, methods, or medical devices

1. The testing entity submits one set of files in accordance with Article 20 of this Circular to the Ministry of Health (Science and Technology Department).

2. Within ten working days from the date of receipt of the files, the Science and Technology Department checks the completeness and validity of the files. In case the files are complete and valid, the Science and Technology Department organizes an Evaluation Team in accordance with Article 28 of this Circular to conduct an on-site evaluation at the testing entity within fifteen working days. In case the files are incomplete or invalid, the Science and Technology Department issues a notification to the testing entity.

3. The Evaluation Team conducts an actual evaluation of the implementation of GCP at the testing entity according to the GCP standards stipulated in Appendix XXI attached to this Circular.

4. Based on the results of the on-site evaluation at the testing entity, the Evaluation Team exchanges with the testing entity regarding the contents of the GCP compliance assessment and prepares an evaluation record in Form 02 of Appendix XXIII attached to this Circular, which determines the level of GCP compliance of the testing entity in accordance with Article 19 of this Circular.

Article 22. Process for Evaluating Compliance with Good Clinical Practice for Testing New Techniques, Methods, or Medical Devices

1. The Evaluation Team announces the Decision establishing the Evaluation Team; the purpose, content, and plan of the evaluation at the testing entity.

2. The testing entity presents a summary of its organization, personnel, activities in implementing and applying GCP or other issues relevant to the evaluation content.

3. The Evaluation Team conducts an actual evaluation of the implementation of GCP at the testing entity according to each specific evaluation content.

4. The Evaluation Team meets with the testing entity to inform about the level of GCP compliance of the testing entity in accordance with Article 19 of this Circular, the non-compliant contents that need to be rectified and corrected during the evaluation process (if any); discusses with the clinical trial entity if there is disagreement between the testing entity and the Evaluation Team on each content.

5. Establish and sign the evaluation record: The evaluation record is signed and confirmed by the Leader of the clinical trial entity and the Head of the Evaluation Team; the record must include the members of the Evaluation Team, location, time, scope of the evaluation, list and detailed analysis of non-compliant contents that the testing entity needs to rectify and correct (if any), compared with the corresponding provisions of this Circular, assess the level of GCP compliance of the testing entity in accordance with Article 19 of this Circular, unresolved issues between the Evaluation Team and the testing entity related to the compliance assessment (if any). The record is established in one copy: one copy retained by the testing entity, one copy retained by the file receiving agency.

Article 23. Handling Results of Compliance Assessment with Good Clinical Practice for Testing New Techniques, Methods, or Medical Devices

1. In case the evaluation record concludes that the clinical trial entity for new techniques, methods, or medical devices complies with GCP as stipulated in Clause 1, Article 19 of this Circular, within ten working days from the date of signing the evaluation record, the Minister of Health instructs the Science and Technology Department to issue a Certificate of GCP Compliance in Form 03 stipulated in Appendix XXIII attached to this Circular.

2. In case the evaluation record concludes that the clinical trial entity for new techniques, methods, or medical devices needs to rectify and correct as stipulated in Clause 2, Article 19 of this Circular:

a) Within five working days from the end date of the on-site evaluation at the clinical trial entity for new techniques, methods, or medical devices and signing the evaluation record, the Science and Technology Department sends the evaluation record of GCP compliance along with a notification of the contents that need to be rectified and corrected to the clinical trial entity for new techniques, methods, or medical devices.

b) After completing the rectification and correction, the clinical trial entity for new techniques, methods, or medical devices must submit a report accompanied by evidence (documentary files, images, videos, certificates) proving the completion of the rectification and correction of the contents recorded in the evaluation record.

c) Within twenty days from the date of receipt of the rectification and correction report from the clinical trial entity for new techniques, methods, or medical devices, the Science and Technology Department reviews the rectification report of the clinical trial entity for new techniques, methods, or medical devices and concludes on the compliance status of the clinical trial entity for new techniques, methods, or medical devices: - If the rectification and correction of the clinical trial entity for new techniques, methods, or medical devices meet the requirements: The Science and Technology Department implements in accordance with Clause 1 of this Article. - If the rectification and correction of the clinical trial entity for new techniques, methods, or medical devices do not meet the requirements: The Science and Technology Department issues a notice requesting further rectification, correction, and supplementation until the requirements are met.

d) Within six months from the date the Science and Technology Department issues a notice requesting rectification and correction, if the clinical trial entity does not submit a rectification and correction report as required, the submitted files will lose their value and the compliance assessment must be conducted again from the beginning.

3. In case the Inspection Report on Compliance with Good Clinical Practice (GCP) concludes that the clinical trial site for new techniques, methods, or medical devices does not comply with GCP as stipulated in Clause 3, Article 19 of this Circular: Within five working days from the date of completing the on-site inspection and signing the Inspection Report, the Department of Science, Technology and Training shall issue a notification regarding non-compliance with GCP, attaching the GCP Inspection Report to the clinical trial site for new techniques, methods, or medical devices, and shall not issue a certificate of compliance with GCP.

4. Within five working days from the date of issuing the certificate of compliance with GCP, the Department of Science, Technology and Training shall publish on the Ministry of Health's electronic portal and the Department of Science, Technology and Training's electronic portal the following information:

a) The name and address of the clinical trial site for new techniques, methods, or medical devices that comply with GCP;

b) The name of the person responsible for professional matters and the number of their practice license (in cases where the clinical trial site is a healthcare facility);

c) The number of the certificate of compliance with GCP (if applicable);

d) The validity period of the compliance assessment and the date of the next periodic assessment;

đ) The scope of activities of the clinical trial site.

Section 3

PERIODIC ASSESSMENT OF THE MAINTENANCE OF COMPLIANCE WITH GOOD CLINICAL PRACTICE FOR NEW TECHNIQUES, METHODS, OR MEDICAL DEVICE TESTING ON CLINICAL TRIALS

Article 24. Periodic Assessment of the Maintenance of Compliance with Good Clinical Practice for New Techniques, Methods, or Medical Device Testing on Clinical Trials

1. Annually, in December, the Department of Science, Technology and Training shall publish on its electronic portal a list of clinical trial sites required to undergo a periodic maintenance compliance assessment with GCP for the following year.

2. Based on the published list by the Department of Science, Technology and Training, the clinical trial site must submit an application for a periodic maintenance compliance assessment with GCP as prescribed in Clause 6 of this Article to the Department of Science, Technology and Training at least sixty days before the expiration date of the previously issued certificate of compliance with GCP.

3. If the clinical trial site for new techniques, methods, or medical devices fails to submit the application for a periodic assessment within the time limit specified in Clause 2 of this Article, within fifteen working days from the submission deadline, the Department of Science, Technology and Training shall issue a notice requiring the site to submit the application as prescribed.

4. Within forty-five days from the issuance of the notice, the clinical trial site must submit a report on its activities and maintenance of compliance with GCP, along with an explanation for the delay in submitting the report. If the site fails to submit the report after this period, the Department of Science, Technology and Training will conduct an unannounced inspection and check the maintenance of compliance with GCP according to the provisions of Article 27 of this Circular.

5. After submitting the application for a periodic maintenance compliance assessment with GCP within the prescribed timeframe, the clinical trial site may continue to conduct clinical trials for new techniques, methods, or medical devices within the scope defined in the previously issued certificate of compliance with GCP until the results of the periodic assessment of compliance with GCP principles and standards are obtained, and must ensure continued compliance with GCP principles and standards.

6. The application for a periodic maintenance compliance assessment with GCP includes:

a) An application form for a periodic maintenance compliance assessment with GCP according to Form No. 04 prescribed in Appendix XXIII attached to this Circular;

b) A summary report on the clinical trial activities of new techniques, methods, or medical devices conducted by the clinical trial site over the last three years from the date of the previous assessment (excluding any unannounced inspections, audits, or checks by the Ministry of Health or the Provincial Health Departments) up to the date of the application for the periodic assessment;

c) Updated documentation on the physical facilities, technical conditions, and personnel of the clinical trial site (if there have been changes).

7. The procedures and handling of the results of the maintenance compliance assessment with GCP shall be carried out according to the provisions of Articles 22 and 23 of this Circular.

Article 25. Handling the Results of Periodic Assessment of Compliance with Good Clinical Practice (GCP) for Testing New Techniques, New Methods, or Medical Devices Clinically

1. In cases where the GCP Evaluation Report concludes that the clinical trial receiving entity complies with GCP as stipulated in Clause 1, Article 19 of this Circular: Within ten working days from the date of completion of the on-site evaluation at the clinical trial receiving entity and signing of the evaluation report, the Department of Science, Technology and Training shall issue a certificate of compliance with GCP according to Form No. 03 prescribed in Appendix XXIII attached to this Circular.

2. In cases where the GCP Evaluation Report concludes that the clinical trial receiving entity needs to rectify and correct deficiencies as stipulated in Clause 2, Article 19 of this Circular:

a) Within five working days from the date of completion of the on-site evaluation at the clinical trial receiving entity and signing of the evaluation report, the Department of Science, Technology and Training shall issue a document requesting the clinical trial receiving entity to rectify and correct deficiencies and submit a rectification report to the Department of Science, Technology and Training.

b) Within forty-five days from the date the Department of Science, Technology and Training issues the request, the clinical trial receiving entity must complete the rectification and correction and submit a report accompanied by evidence (documentary files, images, videos, certificates) proving the completion of the rectification and correction of deficiencies recorded in the evaluation report.

c) Within twenty working days from the date of receipt of the rectification and correction report accompanied by evidence (documentary files, images, videos, certificates), the Department of Science, Technology and Training shall evaluate the results of the rectification by the clinical trial receiving entity and conclude on the compliance status of the entity as follows:

- If the rectification by the clinical trial receiving entity meets the requirements: The Department of Science, Technology and Training shall issue a certificate of compliance with GCP according to Form No. 03 prescribed in Appendix XXIII attached to this Circular.

- If the rectification by the clinical trial receiving entity does not meet the requirements: The Department of Science, Technology and Training shall issue a document requesting further rectification and correction and submission of additional reports. The extended period for continued rectification, correction, and reporting is forty-five days from the date of issuance of the request.

d) Within ninety days from the date of completion of the on-site evaluation if the clinical trial receiving entity does not submit a rectification report or if the rectification results still do not meet the requirements after rectification as stipulated in Point c of this Clause, the Department of Science, Technology and Training shall issue a notification of non-compliance with GCP and, depending on the nature and severity of the violation, implement one or more measures as prescribed in Points a and b of Clause 3 of this Article.

3. In cases where the GCP Evaluation Report concludes that the clinical trial receiving entity does not comply with GCP as stipulated in Clause 3, Article 19 of this Circular: Within five working days from the date of completion of the evaluation at the clinical trial receiving entity and signing of the evaluation report, based on the assessment of risks associated with the quality of research, health, and safety of participants in testing new techniques, new methods, and medical devices, the Department of Science, Technology and Training shall issue a notification of non-compliance with GCP and, depending on the nature and severity of the violation, implement one or more of the following measures:

a) Recommend the competent authority to impose administrative penalties in accordance with the law on handling administrative violations.

b) Revoke the Certificate of Compliance with GCP previously issued to the clinical trial receiving entity.

4. Within five working days from the date of conclusion that the clinical trial receiving entity maintains compliance with GCP or from the date of issuance of the Decision to Revoke the Certificate of Compliance with GCP, the Department of Science, Technology and Training shall update information on its electronic website in accordance with Clause 4, Article 23 of this Circular for clinical trial receiving entities that comply with GCP or information about the revocation of the Certificate of Compliance with GCP for entities that fail to maintain compliance with GCP.

Article 26. Control of Changes

1. During the period between periodic assessments, the testing facility must submit an application for a GCP compliance assessment or report changes according to Form No. 05 stipulated in Appendix XXIII attached hereto if it falls under any of the following circumstances:

a) Change in the scope of the GCP certification;

b) Change in the location of clinical trials for new techniques, methods, or medical devices; change in the position of one of the technical rooms serving clinical trials for new techniques, methods, or medical devices (consultation room, treatment room, emergency room, laboratory) at a new location;

c) Change or addition to one of the technical rooms serving clinical trials for new techniques, methods, or medical devices (consultation room, treatment room, emergency room, laboratory) at the same location for clinical trials for new techniques, methods, or medical devices;

d) Administrative information changes regarding the name or address of the testing facility, updating related information about the testing facility, changing the names of departments or units within the testing facility related to clinical trials for new techniques, methods, or medical devices.

2. In cases where the testing facility for new techniques, methods, or medical devices has changes as prescribed in points a and b of Clause 1 of this Article, the facility must submit an application for a GCP compliance assessment in accordance with Article 20 of this Circular. The procedures for assessing compliance with GCP, classifying results, and handling the results of GCP compliance assessments shall be carried out in accordance with the provisions of Articles 22 and 23 of this Circular.

3. In cases where the testing facility has changes as prescribed in points c and d of Clause 1 of this Article, the testing facility must send a written report on the changes along with corresponding documents to the Department of Science, Technology, and Training.

Article 27. Unannounced Assessment of Compliance with Good Clinical Practice for New Techniques, Methods, or Medical Device Trials

1. An unannounced assessment of compliance with GCP at the testing facility shall be conducted in any of the following circumstances:

a) The testing facility fails to submit a report on maintaining compliance with GCP as required by Article 24 of this Circular;

b) The testing facility makes changes or additions as prescribed in point c of Clause 1 of Article 26 of this Circular, which may affect the accuracy and integrity of research data from clinical trials or impact the safety and rights of participants in clinical trials;

c) The testing facility for new techniques, methods, or medical devices has inspection or audit results from competent authorities concluding serious violations of GCP principles and standards;

d) There is information reflecting or recommending that the testing facility for new techniques, methods, or medical devices seriously violates GCP principles and standards.

2. The file, procedures, and processes for conducting an unannounced assessment at the testing facility shall be carried out in accordance with the provisions of Clauses 6 and 7 of Article 24 of this Circular.

Section 4

ASSESSMENT TEAM FOR COMPLIANCE WITH GOOD CLINICAL PRACTICE FOR NEW TECHNIQUES, METHODS, AND MEDICAL DEVICE TRIALS

Article 28. Composition and criteria for members of the Evaluation Team

1. The Minister of Health shall establish an evaluation team to assess compliance with Good Clinical Practice (GCP) with the following components:

a) A representative from the Department of Science, Technology and Training serving as the head of the team;

b) A representative from the Legal Affairs Department serving as the deputy head of the team;

c) A representative from the Department of Infrastructure and Medical Equipment serving as the deputy head of the team (in cases where the evaluation team assesses GCP compliance for units receiving medical equipment testing);

c) Members representing units under the Ministry of Health, including: the Department of Science, Technology and Training; the Department of Medical Examination and Treatment Management; the Legal Affairs Department; the Department of Infrastructure and Medical Equipment; the Department of Traditional Medicine Management; the National Bioethics Council;

đ) Members representing the Provincial Health Departments (hereinafter referred to as Provincial Health Departments) where the unit receiving testing has its main office;

e) Members who are experts in fields related to the scope of the assessment. Relevant agency or unit representatives may be included if necessary;

g) A member from the Department of Science, Technology and Training serving as the Secretary of the Evaluation Team.

2. The permanent Evaluation Team for GCP compliance established under Clause 1 of this Article shall be located at the Department of Science, Technology and Training - Ministry of Health. The head of the evaluation team invites suitable members for each specific evaluation case.

3. Staff participating in the Evaluation Team must meet the following criteria if they are experts in fields related to the scope of the assessment:

a) Having a bachelor’s degree or higher;

b) Have been trained in GCP and GCP evaluation;

c) Be honest, impartial, and strictly comply with regulations and laws during the evaluation process, without conflicts of interest with the unit receiving testing as stipulated in Clause 4 of this Article.

4. Conflict of Interest Assessment Principle: An Evaluation Team member will be considered to have a conflict of interest with the unit receiving testing if they fall into one of the following situations:

a) Have worked for the unit receiving testing within the last five years;

b) Have participated in advisory activities for the unit receiving testing within the last five years;

c) Currently have financial interests with the unit receiving testing;

d) Have a spouse, child, parent, full sibling, or full sibling of a parent, spouse, or child working for the unit conducting clinical trials on new techniques, methods, or medical devices being evaluated.

Article 29. Responsibilities and Authorities of the Evaluation Team and Responsibilities of the Unit Receiving Testing

1. Responsibilities of the Inspection Team:

a) Assess all activities of the unit receiving testing according to the principles and standards of GCP as specified in Article 17 of this Circular and relevant technical regulations; record specific contents of the assessment, issues, and non-uniform opinions between the Evaluation Team and the unit receiving testing (if any); prepare an assessment report;

b) Maintain confidentiality over all information related to the assessment period and all information related to the clinical trial activities of new techniques, methods, or medical devices conducted by the unit receiving testing; except when there is consent from the unit or upon request from competent state authorities for inspection, supervision, or investigation purposes.

2. Authorities of the Inspection Team:

a) Inspect all areas related to the clinical trial activities of new techniques, methods, or medical devices conducted by the unit receiving testing;

b) Request provision of relevant documentation related to the clinical trial activities of new techniques, methods, or medical devices conducted by the unit receiving testing;

c) Collect evidence through documentation (photocopies of documents, photographs, videos) to prove findings discovered during the assessment process;

d) Prepare a report and require the unit receiving testing to temporarily suspend clinical trial activities of new techniques, methods, or medical devices if the Evaluation Team discovers serious violations affecting the accuracy, honesty of research data, and/or safety and health of participants in clinical trials of new techniques, methods, medical devices, and report to the authority responsible for handling according to regulations.

3. Responsibilities of the unit receiving testing:

a) Organize implementation of this Circular in accordance with the actual conditions of the unit;

b) Ensure compliance with GCP principles and standards throughout the operation of the unit;

c) Conduct clinical trial activities of new techniques, methods, or medical devices strictly within the permitted scope based on compliance with legal provisions;

d) Adhere to legal provisions regarding deadlines, documentation, and procedures for assessing GCP compliance as stipulated in this Circular;

đ) Accept inspections, audits, and sudden assessments of GCP maintenance by competent state authorities as prescribed by law.

Chapter VI

STANDARDS AND HEALTH CHECKS

Section 1

GENERAL PROVISIONS ON STANDARDS AND HEALTH CHECKS

Article 30. Subjects of Health Examination

1. Subjects of health examination:

a) Health examination for Vietnamese citizens and foreigners residing and working in Vietnam: regular health check-ups; health classification examinations for studying and working; health examinations for students;

b) Health examination upon request;

c) Health examination for Vietnamese citizens going to work abroad under contracts.

2. The health examinations provided in this Chapter shall not apply to the following cases:

a) Outpatient and inpatient medical examinations at healthcare facilities;

b) Medical forensic examinations, forensic medical examinations, forensic psychiatric examinations;

c) Examinations for issuing injury certificates;

d) Occupational disease examinations;

e) Health examinations for subjects under the management authority of the Ministry of National Defense and the Ministry of Public Security;

f) Health examinations for special industries and professions.

Article 31. Principles for Implementing Health Examinations

1. Health examinations shall be conducted at healthcare facilities that have been granted licenses to operate medical services according to the provisions of the Law on Medical Examination and Treatment.

2. Mobile health examinations at agencies, organizations, and units shall be carried out in accordance with the provisions of Article 79 of the Law on Medical Examination and Treatment and Articles 82 and 83 of Decree No. 96/2023/NĐ-CP.

3. For individuals holding health examination certificates issued by authorized foreign healthcare facilities, such certificates may be used if there is a mutual recognition agreement between Vietnam and the country or territory issuing the certificate, and the validity period of the certificate does not exceed six months from the date of issuance. The health examination certificate must be translated into Vietnamese and certified.

Article 32. Use of Health Standards for Health Classification

1. The health classification of individuals undergoing health examinations shall be carried out according to the health classification standards issued by the Ministry of Health for recruitment and regular health examinations of workers.

2. In cases where health examinations are conducted based on specialized health standards issued or recognized by competent state management authorities in Vietnam, the health classification shall be based on the provisions of those specialized health standards.

3. In cases where health examinations are conducted upon request and do not cover all specialties as specified in the health examination form issued under this Circular, the healthcare facility shall only conduct and conclude examinations for each specialty requested and shall not classify health status.

Article 33. Costs of Health Examinations

1. Organizations and individuals requesting health examinations must pay the costs of health examinations to the healthcare facility according to the approved service fees for medical examination and treatment by the competent state authority or through an agreement between the two parties, except in cases exempted or reduced according to the law.

2. If the person undergoing health examination requests two or more health examination certificates, they must pay additional fees for issuing the health examination certificates as stipulated by the healthcare facility.

3. The collection, submission, management, and utilization of revenue from health examination activities shall be carried out in accordance with the law.

Section 2

HEALTH RECORDS, PROCEDURES, CONTENTS, AND HEALTH CLASSIFICATIONS

Article 34. Health Examination File

1. The health examination file for individuals aged 18 years or older shall be a health examination certificate according to Model No. 01 of Appendix No. XXIV issued together with this Circular, bearing a portrait photograph measuring 04cm x 06cm, taken against a white background within six months prior to the date of submission of the health examination file.

2. The health examination file for individuals under 18 years old shall be a health examination certificate according to Model No. 02 of Appendix No. XXIV issued together with this Circular, bearing a portrait photograph measuring 04cm x 06cm, taken against a white background within six months prior to the date of submission of the health examination file.

3. For individuals who have lost or are restricted in their capacity for civil acts and request a health examination but do not fall under the regular health examination cases, the health examination file shall include:

a) A health examination certificate as prescribed in Clause 1 or Clause 2 of this Article;

b) A consent document of the patient's relatives as stipulated in Clause 11, Article 2 of the Law on Medical Examination and Treatment.

4. For individuals undergoing regular health examinations, the health examination file shall include:

a) A regular health examination book according to Model No. 03 of Appendix No. XXIV issued together with this Circular;

b) An introduction letter from the organization or entity where the individual is working for single regular health examinations or included in the list of regular health examinations confirmed by the organization or entity where the individual is working to perform regular health examinations as per the contract.

Article 35. Health Examination Process

1. Individuals coming for health examinations shall submit the file according to the prescribed model at the health examination facility.

2. After receiving the health examination file, the health examination facility shall proceed as follows:

a) Compare the photograph in the health examination file with the person coming for the examination;

b) Stamp over the photograph after comparison as prescribed in Point a of this Clause for cases specified in Clauses 1, 2, and 3 of Article 37 of this Circular;

c) Check and compare valid identification documents of the patient's relatives as prescribed in Clause 3 of Article 37 of this Circular;

d) Guide the health examination process of the unit to the person being examined or the guardian of the person being examined (if applicable);

e) The health examination facility shall establish, issue, and implement the health examination process;

f) Return the results and retain the health examination file.

Article 36. Content of Health Examinations

1. For health examinations of individuals aged 18 years or older but not falling under regular health examinations: Examine according to the contents recorded in the health examination certificate as prescribed in Model No. 01 of Appendix No. XXIV issued together with this Circular.

2. For health examinations of individuals under 18 years old but not falling under regular health examinations: Examine according to the contents recorded in the health examination certificate as prescribed in Model No. 02 of Appendix No. XXIV issued together with this Circular.

3. For regular health examinations: Examine according to the contents recorded in the regular health examination book as prescribed in Model No. 03 of Appendix No. XXIV issued together with this Circular.

4. For female workers, during regular health examinations, they shall undergo specialized obstetric and gynecological examinations according to the list prescribed in Appendix No. XXV issued together with this Circular.

5. All contents must be thoroughly examined according to each specialty. In difficult cases, consultations or orders for clinical tests shall be made to diagnose definitively and assess the degree of illness or disability as a basis for classifying health status.

6. For health examinations conducted upon request, only specific conclusions for each specialty as requested shall be provided without classifying health status.

Article 37. Health Classification

1. The criteria for health classification of individuals undergoing health examinations shall be implemented in accordance with the regulations of the Minister of Health.

2. Based on the results of specialized medical examinations, the person conducting the specialized examination shall clearly record diseases and disabilities within the specialized field examined and classify health according to the assigned specialized field.

3. Based on the results of each specialized examination, the practitioner assigned by the health examination facility to conclude the health classification and sign the health examination certificate or periodic health examination book (hereinafter referred to as the classifier) shall conduct the health classification conclusion as follows:

a) Conduct health classification for individuals undergoing health examinations in accordance with the regulations of the Minister of Health regarding the issuance of health classification standards for recruitment health examinations and periodic health examinations for workers;

b) In cases where individuals undergoing health examinations have diseases or disabilities, the classifier shall advise treatment plans, functional recovery measures, or refer them for further medical examination and treatment.

4. After classifying health, the classifier must sign, clearly write their name, and affix the stamp of the health examination facility on the health examination certificate or periodic health examination book. The stamp used in formal transactions of the health examination facility shall comply with the legal regulations on the management and use of seals.

5. For cases of health examinations conducted according to specialized health standards issued or recognized by competent state management agencies in Vietnam, the health classification shall be based on the provisions of those specialized health standards.

6. For cases of health examinations conducted upon request but not fully covering all specialized fields as stipulated in this Circular's health examination form, the medical and healthcare facility conducting the health examination shall only examine and conclude for each specialized field requested by the individual undergoing the health examination and shall not conduct health classification.

Article 38. Issuance and Retention of Health Examination Certificates

1. A health examination certificate shall be issued one copy to the individual undergoing the health examination and one copy retained at the health examination facility. The retention period for health examination records shall be carried out in accordance with the provisions of Item 20 Group 01 Medical Examination and Treatment and Rehabilitation Documentation accompanying Circular No. 53/2017/TT-BYT dated December 29, 2017, issued by the Minister of Health, concerning the retention period of medical and professional documentation in the health sector. Periodic health examination records shall be managed and stored by the entity managing the individual undergoing the health examination.

2. In cases where the individual undergoing the health examination requests multiple health examination certificates, the health examination facility shall duplicate the health examination certificate. Duplication shall be carried out in accordance with the provisions of Government Decree No. 30/2020/NĐ-CP dated March 5, 2020, on archival work (hereinafter referred to as Decree No. 30/2020/NĐ-CP).

3. Time limit for issuing health examination certificates and periodic health examination books:

a) For individual health examinations: the health examination facility shall issue the health examination certificate and periodic health examination book to the individual undergoing the health examination within twenty-four hours from the end of the health examination, except in cases requiring additional examination or testing as required by the examiner;

b) For group health examinations under contract: the health examination facility shall issue the health examination certificate and periodic health examination book to the individual undergoing the health examination in accordance with the agreement recorded in the contract.

4. Validity of health examination certificates and periodic health examination results:

a) Health examination certificates are valid for twelve months from the date of signing the health examination conclusion;

b) Periodic health examination results are valid for use in accordance with legal provisions.

Chapter VII

MOBILIZATION AND RELOCATION OF PERSONS PARTICIPATING IN MEDICAL EXAMINATION AND TREATMENT ACTIVITIES IN CASES OF NATURAL DISASTERS, DISASTROUS EVENTS, INFECTIOUS DISEASES BELONGING TO GROUP A OR EMERGENCY SITUATIONS

Article 39. Mobilization and Deployment of Personnel for Medical Examination and Treatment Activities in Case of Natural Disasters, Catastrophes, Group A Infectious Diseases, or Emergency Situations

1. In cases where the human resources of units or localities are insufficient to meet the requirements of medical examination and treatment activities during natural disasters, catastrophes, group A infectious diseases, or emergency situations, apart from mobilizing and deploying personnel with expertise suitable for the prevention and control of natural disasters, catastrophes, group A infectious diseases, or emergency situations as prescribed by law, competent authorities are permitted to mobilize and deploy the following individuals to participate in medical examination and treatment activities, including testing, sample collection, vaccination, first aid, and emergency care:

a) Medical practitioners practicing in Vietnam (including foreigners) may perform testing, vaccination, medical examinations, treatments, first aid, and emergency care outside the scope of their licensed medical practice;

b) Foreigners and overseas Vietnamese residents who have been authorized by foreign competent authorities to practice medical examinations and treatments may perform testing, vaccination, first aid, emergency care, and other medical examination and treatment activities at healthcare facilities established to handle or assigned the task of receiving, providing emergency care, managing, and treating patients infected with group A infectious diseases or those requiring first aid, emergency care, and treatment due to natural disasters, catastrophes, or emergency situations without needing a medical practice license issued by Vietnamese competent authorities;

c) Students, pupils, and trainees from health-related schools; individuals eligible for a medical practice license but not yet issued such a license may participate in testing, vaccination, group A infectious disease medical examinations and treatments, first aid, emergency care, and medical examinations and treatments for patients affected by natural disasters, catastrophes, or emergency situations.

Article 40. Basis and Authority for Mobilization and Deployment of Personnel for Testing, Vaccination, Medical Examination, and Treatment Activities in Cases of Natural Disasters, Catastrophes, Group A Infectious Diseases, or Emergency Situations

1. The basis for mobilizing and deploying personnel for testing, vaccination, medical examination, and treatment activities in cases of natural disasters, catastrophes, group A infectious diseases, or emergency situations:

a) At the request of the Chairperson of the People's Committees of provinces and centrally-administered cities, Directors of Health Departments, Chairpersons of the People's Committees of districts, towns under provincial-level cities, and centrally-administered cities in need of support in human resources for testing, vaccination, medical examination, and treatment activities during natural disasters, catastrophes, group A infectious diseases, or emergency situations, according to the model specified in Appendix XXVII attached to this Circular;

b) At the request of the Heads of medical examination and treatment facilities, infectious disease reception and treatment facilities, and preventive healthcare facilities in need of support in human resources for preventing and controlling group A infectious diseases or providing emergency care and treatment for patients during natural disasters, catastrophes, or emergency situations;

c) At the deployment by the Minister of Health to supplement human resources to support localities, medical examination and treatment facilities, and preventive healthcare facilities to strengthen forces participating in the prevention and control of group A infectious diseases or providing emergency care and treatment for patients during natural disasters, catastrophes, or emergency situations.

2. Authority for Mobilizing and Deploying Personnel for Testing, Vaccination, Medical Examination, and Treatment Activities in Cases of Natural Disasters, Catastrophes, Group A Infectious Diseases, or Emergency Situations:

a) The Minister of Health mobilizes and deploys forces to participate in the prevention and control of group A infectious diseases and provide emergency care and treatment for patients during natural disasters, catastrophes, or emergency situations nationwide, except for forces managed by the Ministry of National Defense and the Ministry of Public Security;

b) The Chairperson of the People's Committee of a province or centrally-administered city, or a unit authorized by the People's Committee of a province or centrally-administered city to mobilize and deploy forces to participate in the prevention and control of group A infectious diseases and provide emergency care and treatment for patients during natural disasters, catastrophes, or emergency situations within their jurisdiction;

c) The Heads of medical examination and treatment facilities, infectious disease reception and treatment facilities, preventive healthcare facilities, and health-related training institutions mobilize and deploy forces to participate in the prevention and control of group A infectious diseases and provide emergency care and treatment for patients during natural disasters, catastrophes, or emergency situations within their management scope.

Article 41. Acceptance and Assignment of Personnel for Testing, Vaccination, Diagnosis, Treatment of Group A Infectious Diseases, Emergency Rescue, and Treatment During Natural Disasters, Catastrophes, or Emergencies

1. The Director of the Department of Health shall accept and assign personnel mobilized and called up by competent authorities to each facility to perform tasks related to vaccination, testing, diagnosis, treatment of Group A infectious diseases, emergency rescue, and treatment during natural disasters, catastrophes, or emergencies.

2. The heads of medical examination and treatment facilities, quarantine and treatment centers, preventive healthcare facilities, and health training institutions shall implement the acceptance and detailed assignment of tasks to positions and personnel suitable for the professional requirements of preventing and controlling Group A infectious diseases or participating in emergency rescue and treatment during natural disasters, catastrophes, or emergencies.

Chapter VIII

ON-DUTY DIAGNOSIS AND TREATMENT

Article 42. Subjects of On-Duty Diagnosis and Treatment

On-duty diagnosis and treatment as stipulated in this Chapter apply to medical examination and treatment facilities with inpatient beds; medical examination and treatment facilities with observation beds; and off-site emergency care facilities (hereinafter referred to as medical examination and treatment facilities).

Article 43. Principles of On-Duty Diagnosis and Treatment

1. Out-of-office hours, holidays, and weekends must be organized by medical examination and treatment facilities to ensure continuous 24/24 hours operation for diagnosis and treatment.

2. Shifts must be organized tightly, with sufficient human resources, transportation means, medical equipment, and medicines for emergency treatment of patients.

3. Duty positions must ensure easy access and adequate communication information.

4. Duty personnel must be present before their shift to receive handover from the previous shift and when the shift ends, they must hand over to the next shift, may not leave their duty position, and must comply with superior orders.

5. Lists of duty personnel assigned monthly, duty schedules published at least one week before the duty period, signed and approved by hospital leadership, and recorded on boards at each duty position. Civil servants, public officials, and employees assigned to duty according to the schedule can only swap shifts with approval from leadership.

Article 44. Duties of Positions on Duty in Hospitals

1. Leadership Duty:

a) Leadership duty subjects: Directors, deputy directors, and department chiefs designated by the director to participate in regular leadership duties and must be authorized in writing.

b) Duties of leadership duty:

- Inspect and urge all shifts in the hospital.

- Direct the resolution of issues and difficult situations beyond the professional capacity of lower-level duty personnel.

- Direct the handling of unusual incidents concerning security and order occurring in the hospital.

- Report to the direct management authority of the hospital about special and sudden cases exceeding the authority to resolve.

2. Clinical Duty:

a) Organization of clinical duty:

- The head of the shift is a practicing physician holding the position of chief of department, deputy chief of department, or a doctor with postgraduate qualifications.

- Clinical duty doctors are practicing physicians with sufficient qualifications, capable of independently resolving work and responsible for the resolution plan.

- Nurses, midwives, and medical technicians are practicing personnel assigned to clinical duty by the hospital director.

b) Duties of the head of the clinical duty shift:

- Manage human resources during the shift.

- Examine and direct the resolution of emergency cases, new arrivals, and critically ill patients undergoing treatment with abnormal developments when the clinical duty doctor of the department cannot resolve them.

- Report and seek guidance from the leadership duty in cases exceeding professional capacity and special cases such as suicide, epidemics, disasters, mass rescues.

- Notify the security duty and report to the leadership duty in case of security breaches in the hospital. - Inspect and urge other duty positions.

c) Duties of clinical duty doctors:

- Receive patients coming for emergency treatment.

- Monitor and handle patients handed over.

- Guide and urge duty members to fully implement directives.

- Assign responsibilities to each duty member to closely monitor and promptly address adverse developments in critically ill patients under level one care.

- Examine patients and record medical records after each examination.

d) Duties of nursing, midwifery, and medical technical duty personnel:

- Nursing duty personnel are nurses from each department who can organize inter-departmental nursing duty as decided by the hospital director.

- Implement physician's instructions, care for and monitor patients. - Urge patients to follow hospital rules.

- Safeguard patient files, medicine cabinets, and department assets.

- Detect abnormal developments in patients with risk of death, report to the clinical duty doctor, and record all developments in the monitoring form.

3. Adjunct Clinical Duty:

a) Organize separate duty for each specialty, arranging the number of duty personnel based on workload in each department.

b) Duties of adjunct clinical duty: Perform techniques serving diagnosis and treatment according to the instructions of clinical duty.

4.后勤保障和管理值班:

a) 药品和医疗设备值班人员负责确保提供充足的药品和运行医疗设备以支持值班团队;

b) 财务会计值班人员负责确保在非工作时间收取前来就诊和出院患者的住院费用;

c) 信息技术值班人员负责确保医院管理系统正常运行;

d) 电力和水供应值班人员负责确保在突发断电情况下发电机的运行，并修复异常的电力和供水故障;

戊) 行政值班必须保证通过电话和其他形式(根据医疗机构的规定)的信息沟通;

e) 安保值班负责确保医院内的安全和秩序;

己) 驾驶员值班必须确保救护车随时待命执行任务;

5. 外院常驻值班:

a) In addition to those persons assigned to duty at the four levels of permanent duty mentioned above, the hospital leadership may arrange for permanent off-site duty personnel based on the actual conditions of each hospital to be ready to provide professional and administrative support when necessary.

c) Persons assigned to permanent off-site duty must maintain continuous communication during their assigned duty period and be present at the hospital when mobilized.

Article 45. Content of Duty Report

1. After the duty shift, all duty departments must fully record the report content in the duty logbook; departments and offices must organize a briefing session to hear the duty situation reports from the duty departments: clinical, paraclinical, logistics, and management.

2. The clinical duty report must ensure that it covers the developments during the duty shift regarding the following contents:

a) Death: Clearly record the patient's condition progression, handling method, cause, time of death, and specific actions taken after the patient's death.

b) Emergency care: Clearly record the name, age, address, diagnosis, and handling method for each patient who received emergency care.

c) Severe progression of inpatient patients: Clearly record the disease progression and handling methods for each patient.

d) Medications: Statistically report the quantity of medications used during the duty shift.

3. Paraclinical duty: Report on the situation of emergency testing and paraclinical techniques performed during the regular duty shift.

4. Logistics and management duty: Report on the contents as prescribed in Clause 4 of Article 44 of this Circular.

5. Leadership duty: Provide general comments on the duty situation at the hospital-wide briefing.

Article 46. Duty at Healthcare Facilities with Non-Hospital Organizational Forms but with Inpatient Beds or Observation Beds

1. Healthcare facilities with non-hospital organizational forms but with inpatient beds or observation beds (except as provided in Clause 2 of this Article) must arrange manpower for one duty shift as follows: At least one person practicing with the title of doctor or physician and one person practicing in one of the following titles: nurse, midwife, or medical technician.

2. For commune health stations, manpower for one duty shift must be arranged as follows: At least one person practicing in one of the following titles: doctor, physician, nurse, midwife, or medical technician.

Article 47. Off-Site Emergency Duty

1. Off-site emergency facilities (including patient transport facilities established in accordance with the Law on Medical Examination and Treatment No. 40/2009/QH12) must ensure the organization of 24/7 emergency duty operations throughout the day (including holidays and weekends) as stipulated in Decision No. 01/2008/QD-BYT dated January 21, 2008, issued by the Minister of Health on the emergency treatment, intensive care, and detoxification regulations.

2. For healthcare facilities with an external emergency scope of operation, the following must be arranged:

a) Manpower for 24/7 duty.

b) The number of people for one duty shift must ensure a minimum of:

- One person practicing with the title of doctor or physician.

- One person practicing in one of the following titles: nurse, midwife, or medical technician.

- One ambulance driver.

c) The manpower for the emergency duty shift specified in Point b of this Clause must be independently arranged from the manpower of other concurrent duty shifts and can be arranged in a permanent duty form.

Chapter IX

ORGANIZATION AND OPERATIONS OF THE SPECIALIZED COUNCIL AND PROCEDURES FOR RESOLVING DISPUTES WHEN MEDICAL INCIDENTS OCCUR

Article 48. Structure of the specialized council

1. The organizational structure and number of members of the specialized council include:

a) Chairman of the council: 01 person;

b) Deputy Chairmen of the council: 01 to 02 persons;

c) Members: At least 03 persons;

d) Secretary of the council: At least 01 person.

2. Principles for establishing the council:

a) Ensuring independence, objectivity, and absence of conflicts of interest;

b) Council members must have a scope of practice or relevant professional qualifications related to medical incidents;

c) The number of council members (including the Chairman of the council) must be an odd number.

Article 49. Activities of the specialized council

1. Conditions for convening a meeting of the specialized council: At least two-thirds of the council members must be present.

2. Sessions of the council:

a) The council may hold one or more sessions;

b) Each member of the council bases their evaluation of medical incidents on the file;

c) The council discusses collectively, concludes based on the majority opinion from the evaluations of the members, and bears legal responsibility for its conclusions;

d) The content discussed at the council session must be recorded in minutes, with signatures of all participating council members.

3. The conclusion of the specialized council must identify the cause of the medical incident:

a) In cases where the medical incident occurs due to causes specified in Clause 2, Article 100 of the Law on Medical Examination and Treatment, the conclusion is that there is no technical error by the practitioner.

b) In cases where the medical incident occurs due to technical errors during medical examination and treatment, the conclusion must specify the following contents: - Whether the practitioner violated any of the circumstances stipulated in Clause 1, Article 100 of the Law on Medical Examination and Treatment. - The degree of technical error and the form of handling for the practitioner (if applicable).

4. The conclusion document signed by the Chairman of the council must contain content consistent with the conclusion in the meeting minutes and be established in two copies, one copy retained by the agency that established the council, one copy sent to the agency requesting the establishment of the council, except when the agency establishing the council is the medical facility where the medical incident occurred. The signature of the Chairman of the council must be verified by the agency that established the council.

5. During the council meeting, if necessary, the Chairman of the council may request the agency that established the council to invite additional experts to participate in the meeting without having to supplement the decision to establish the council.

Article 50. Procedures and formalities for resolving disputes when a medical incident occurs

1. Procedure for resolving disputes in cases where the hospital falls under the management authority of the Department of Health (including hospitals of various ministries and sectors, excluding hospitals directly under the Ministry of National Defense and the Ministry of Public Security):

a) When a medical incident occurs and there is a dispute requiring resolution, upon the request of the patient, the patient's representative, the practitioner, or the criminal investigation agency, court, the hospital must establish a specialized council according to the provisions of Clause 1, Article 101 of the Law on Medical Examination and Treatment (referred to as the grassroots specialized council);

b) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified in point a of this clause, they must submit a written request to the Department of Health to establish a specialized council to resolve the dispute and attach relevant documents related to the dispute;

c) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified in point b of this clause, they must submit a written request to the Ministry of Health to establish a specialized council to resolve the dispute and attach relevant documents related to the dispute. The conclusion of the specialized council of the Ministry of Health is the final conclusion;

d) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified by the Ministry of Health, the parties may initiate litigation at the court.

2. Procedure for resolving disputes in cases where the medical facility falls under the management authority of the Department of Health but is not a hospital (including non-hospital medical facilities of various ministries and sectors, excluding facilities directly under the Ministry of National Defense and the Ministry of Public Security):

a) When a medical incident occurs and there is a dispute requiring resolution, upon the request of the patient, the patient's representative, the practitioner, or the criminal investigation agency, court, the facility must submit a written request to the Department of Health to establish a specialized council to resolve the dispute and attach relevant documents related to the dispute;

b) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified in point a of this clause, they must submit a written request to the Ministry of Health to establish a specialized council to resolve the dispute and attach relevant documents related to the dispute. The conclusion of the specialized council of the Ministry of Health is the final conclusion;

c) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified by the Ministry of Health, the parties may initiate litigation at the court.

3. Procedure for resolving disputes in cases where the hospital or infirmary falls under the management authority of the Ministry of National Defense or the Ministry of Public Security:

a) When a medical incident occurs and there is a dispute requiring resolution, upon the request of the patient, the patient's representative, the practitioner, or the criminal investigation agency, court, the hospital or infirmary must establish a specialized council according to the provisions of Clause 1, Article 101 of the Law on Medical Examination and Treatment (referred to as the grassroots specialized council);

b) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified in point a of this clause, they must submit a written request to the Military Medicine Bureau of the Ministry of National Defense or the Health Bureau of the Ministry of Public Security to establish a specialized council to resolve the dispute and attach relevant documents related to the dispute;

c) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified in point b of this clause, they must submit a written request to the Ministry of Health to establish a specialized council to resolve the dispute and attach relevant documents related to the dispute. The conclusion of the specialized council of the Ministry of Health is the final conclusion;

d) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified by the Ministry of Health, the parties may initiate litigation at the court.

4. Procedure for resolving disputes in cases where the medical facility falls under the management authority of the Ministry of National Defense or the Ministry of Public Security but is not a hospital or infirmary, or is an infirmary but does not meet the conditions to establish a specialized council:

a) In case of medical incidents leading to disputes that need resolution, upon the request of the patient, the patient's representative, the healthcare provider, or the police investigation agency, court, the healthcare facility shall submit a written request to the Military Medical Department of the Ministry of National Defense or the Health Department of the Ministry of Public Security to establish a specialized committee for resolution and attach relevant dispute-related documents.

b) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified in point a of this clause, they must submit a written request to the Ministry of Health to establish a specialized council to resolve the dispute and attach relevant documents related to the dispute. The conclusion of the specialized council of the Ministry of Health is the final conclusion;

c) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified by the Ministry of Health, the parties may initiate litigation at the court.

5. Procedure for resolving disputes in cases where hospitals are under the management authority of the Ministry of Health:

a) In case of medical incidents leading to disputes that need resolution, upon the request of the patient, the patient's representative, the healthcare provider, or the police investigation agency, court, the hospital shall establish a specialized committee according to Clause 1 of Article 101 of the Law on Medical Examination and Treatment (referred to as the specialized committee at the facility level).

b) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified in point a of this clause, they must submit a written request to the Ministry of Health to establish a specialized council to resolve the dispute and attach relevant documents related to the dispute. The conclusion of the specialized council of the Ministry of Health is the final conclusion;

c) In cases where the parties involved in the dispute disagree with the conclusion of the specialized council specified by the Ministry of Health, the parties may initiate litigation at the court.

6. Procedure for resolving disputes in cases where healthcare facilities are under the management authority of the Ministry of Health but are not in the form of a hospital:

a) In case of medical incidents leading to disputes that need resolution, upon the request of the patient, the patient's representative, the healthcare provider, or the police investigation agency, court, the healthcare facility shall submit a written request to the Ministry of Health to establish a specialized committee for resolution and attach relevant dispute-related documents. The conclusion of the specialized committee of the Ministry of Health is the final conclusion.

b) In cases where the disputing parties disagree with the conclusion of the specialized committee established by the Ministry of Health, the parties may initiate litigation before the court.

Chapter X

MEDICAL RECORDS

Article 51. Medical records, forms, and medical certificates used in medical records

1. Attached to this Circular are 82 models of medical records, forms, and medical certificates including:

a) Models of medical records as specified in Appendix XXVIII attached to this Circular;

b) Models of forms and medical certificates as specified in Appendix XXIX attached to this Circular;

Article 52. Provisions on the use of medical records and recording of medical records

1. Provisions on the use of medical records:

a) Healthcare facilities shall use medical records in either paper or electronic format.

b) For healthcare facilities applying electronic medical records, they must ensure that all fields of information in the medical record are complete.

2. Provisions on recording medical records:

a) Accurately, truthfully, and fully record all information in the medical record, examination results, clinical tests, functional examinations, diagnostic and treatment processes, care, and other related information during the treatment process at the healthcare facility;

b) Recording must comply with the contents and professional guidelines already issued;

c) Use clear, scientific language, presented in a readable manner. Abbreviations shall not be used in documents provided to patients including: summary of medical records, transfer documents to other healthcare facilities, referral letters for health insurance medical examination and treatment, appointment letters for follow-up visits. Abbreviations must follow the list of symbols and abbreviations used consistently in the medical records of the healthcare facility;

d) Information in the medical record should clearly indicate the time and recorder.

Chapter XI

IMPLEMENTING PROVISIONS

Article 53. Effective Date

1. This Circular takes effect from January 1, 2024.

2. The following documents shall cease to be effective from the date this Circular comes into force:

a) Circular No. 35/2019/TT-BYT dated December 30, 2019, issued by the Minister of Health, stipulating the scope of professional activities for healthcare providers;

b) Circular No. 55/2015/TT-BYT dated December 29, 2015, issued by the Minister of Health, stipulating the recognition of clinical trials for new techniques and methods in medical examination and treatment;

c) Circular No. 14/2013/TT-BYT dated May 6, 2013, issued by the Minister of Health, guiding health check-ups;

d) Circular No. 09/2023/TT-BYT dated May 5, 2023, issued by the Minister of Health, amending and supplementing certain articles of Circular No. 14/2013/TT-BYT dated May 6, 2013, issued by the Minister of Health, guiding health check-ups;

đ) The on-duty regulations in Clause 1, Part IV of Decision No. 1895/1997/QĐ-BYT dated September 19, 1997, regarding the issuance of hospital regulations;

e) Decision No. 4069/2001/QĐ-BYT dated September 28, 2001, issued by the Minister of Health, concerning medical record and medical chart templates;

g) Model Summary of Medical Records (CV-01), replacing "Model Summary of Medical Records" in Appendix 4 attached to Circular No. 18/2022/TT-BYT dated December 31, 2022, issued by the Minister of Health, amending and supplementing certain articles of Circular No. 56/2017/TT-BYT dated December 29, 2017, issued by the Minister of Health, detailing the implementation of the Social Insurance Law and the Labor Safety and Health Law in the field of health;

h) Decision No. 1941/QĐ-BYT dated May 22, 2019, issued by the Minister of Health, promulgating traditional medicine medical record models for use in traditional medicine healthcare facilities;

i) Decision No. 3730/QĐ-BYT dated August 5, 2021, issued by the Minister of Health, promulgating amendments and supplements to rehabilitation medical record models and some rehabilitation certificate models;

k) Circular No. 41/2011/TT-BYT dated November 14, 2011, issued by the Minister of Health, guiding the issuance of practice certificates for healthcare providers and operating permits for healthcare facilities;

l) Circular No. 41/2015/TT-BYT dated November 16, 2015, issued by the Minister of Health, amending and supplementing certain articles of Circular No. 41/2011/TT-BYT dated November 14, 2011, issued by the Minister of Health, guiding the issuance of practice certificates for healthcare providers and operating permits for healthcare facilities;

m) Provisions on continuous medical knowledge updating in medical examination and treatment as detailed in Circular No. 22/2013/TT-BYT dated August 9, 2013, issued by the Minister of Health, guiding continuous training for healthcare personnel, amended and supplemented by Circular No. 26/2020/TT-BYT dated December 28, 2020, issued by the Minister of Health, amending and supplementing certain articles of Circular No. 22/2013/TT-BYT dated August 9, 2013, issued by the Minister of Health, guiding continuous training for healthcare personnel.

Article 54. Reference Provisions

In cases where the referenced documents in this Circular are replaced, amended, or supplemented, they shall be applied according to the documents that have been replaced, amended, or supplemented.

Article 55. Transitional Provisions

1. In cases where a practitioner has already been issued a practice certificate (hereinafter referred to as a practice permit) in accordance with the Law on Medical Examination and Treatment No. 40/2009/QH12, the scope of practice shall be applied in accordance with the provisions of this Circular.

2. For testing facilities that have been granted a Certificate of Compliance with Good Clinical Practice (GCP) for the scope of clinical drug trials (chemical drugs, herbal drugs, traditional medicine drugs, biological products, therapeutic biological products), the testing facility shall conduct a review and prepare conditions to meet the principles and standards of GCP as stipulated in this Circular and submit the dossier in accordance with Article 20 of this Circular to the Department of Science, Technology and Training.

3. The Department of Science, Technology and Training shall be responsible for inspecting and evaluating compliance with GCP based on the dossier of the testing facility. In cases where the dossier of the testing facility is complete and meets the conditions prescribed in this Circular, the Ministry of Health shall instruct the Department of Science, Technology and Training to issue a certificate of compliance with GCP for the scope of new technique trials, new method trials, and/or clinical trials of medical devices within twenty working days from the date of receipt of a valid dossier.

4. The Department of Science, Technology and Training shall conduct on-site evaluations at testing facilities in any of the following situations:

a) The testing facility requests issuance of a certificate of compliance with good clinical practice for medical device trials;

b) The evidence documents in the dossier regarding the conditions of the testing facility do not comply with the provisions of this Circular;

c) The dossier shows signs of erasure or alteration of information;

d) The testing facility has been penalized by competent authorities for administrative violations related to clinical trials.

5. In cases where on-site evaluations are conducted at testing facilities, the handling of evaluation results shall be carried out in accordance with Article 23 of this Circular.

Article 56. Responsibility for Enforcement

1. The Director of the Ministry's Office, the Director of the Department of Medical Examination and Treatment Management, the Director of the Department of Science, Technology and Training, the Director of the Department of Traditional Medicine and Pharmaceutical Management, the Heads of the Departments under the Ministry of Health, the Heads of the agencies and units directly under the Ministry, the Directors of Provincial Health Departments, the Heads of health agencies of Ministries and sectors, and relevant organizations and individuals are responsible for implementing this Circular. During implementation, if there are difficulties or obstacles, it is recommended that agencies, organizations, and individuals promptly report to the Ministry of Health (Department of Medical Examination and Treatment Management, Department of Science, Technology and Training) for consideration and resolution.

During implementation, if there are difficulties or obstacles, it is recommended that agencies, organizations, and individuals promptly report to the Ministry of Health (Department of Medical Examination and Treatment Management, Department of Science, Technology and Training) for consideration and resolution./.