Circular No. 07/2015/TT-BYT detailing conditions and procedures for permission to apply new techniques and methods in medical examination and treatment

CIRCULAR

Detailed regulations on conditions and procedures for permitting the application of new techniques and methods in medical examination and treatment.

new methods in diagnosis and treatment

                       

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Department of Medical Examination and Treatment,

The Minister of Health issues this Circular detailing the conditions and procedures for permitting the application of new techniques and methods in medical examination and treatment.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 1. This Circular details the conditions and procedures for permitting the application of new techniques and methods in medical examination and treatment.

2. This Circular does not apply to the following cases:

a) New techniques and methods concerning organ and tissue donation, transplantation, and body donation. The application of these new techniques and methods shall be carried out in accordance with the laws on organ and tissue donation, transplantation, and body donation.

b) New techniques and methods concerning gender reassignment, in vitro fertilization, and altruistic surrogacy. The application of these new techniques and methods shall be carried out in accordance with the laws on civil matters, marriage, and family.

c) In cases where new techniques and methods specified in Clause 3, Article 69 of the Medical Examination and Treatment Law fall under Class II, Class III, or are not classified according to the surgical and procedural classification system of the Ministry of Health, medical examination and treatment facilities shall implement them in accordance with Circular No. 43/2013/TT-BYT dated December 11, 2013 issued by the Minister of Health detailing the specialized technical classification system for the medical examination and treatment facility network.

Article 2. Determination of new techniques and methods in medical examination and treatment

Clause 1. New techniques and methods specified in Clause 1, Article 69 of the Medical Examination and Treatment Law are specifically defined as follows:

a) Techniques and methods researched for the first time in Vietnam that have completed research, been accepted by the Bioethics Issues Evaluation Board of the Ministry of Health or the Ministry-level Scientific Council, recommended for permission to apply, and received a Research Result Certificate from the Science, Technology and Training Department of the Ministry of Health.

b) Techniques and methods researched for the first time abroad that have completed research and acceptance in accordance with the regulations of the country of origin, been reviewed and approved by the Bioethics Issues Evaluation Board of the Ministry of Health or the Ministry-level Scientific Council, recommended for permission to apply, and received a Research Result Recognition Certificate from the Science, Technology and Training Department of the Ministry of Health.

Clause 2. New techniques and methods specified in Clause 2, Article 69 of the Medical Examination and Treatment Law are specifically defined as follows:

Techniques and methods that have been permitted by competent authorities in foreign countries and officially applied at least in one medical examination and treatment facility abroad but are being applied for the first time in Vietnam, shall be subject to review and assessment of the expert panel established by the Ministry of Health regarding the application permit request.

Clause 3. New techniques and methods specified in Clause 3, Article 69 of the Medical Examination and Treatment Law are specifically defined as follows:

Techniques and methods classified by the Ministry of Health as special class or Class I surgical and procedural categories, which are being applied for the first time at a medical examination and treatment facility.

Article 3. General principles for applying new techniques and methods

Clause 1. The application of new techniques and methods in medical examination and treatment shall be implemented in two stages: pilot application and official application.

Clause 2. For the techniques and methods specified in Point a, Clause 1, Article 2 of this Circular, the research phase shall be considered as the pilot application stage.

Chapter II
RULES ON THE APPLICATION OF NEW TECHNOLOGIES AND METHODS IN DIAGNOSIS AND TREATMENT

IN DIAGNOSIS AND TREATMENT

Article 4. Conditions Regarding Organization and Human Resources for Medical Diagnostic and Treatment Facilities Intending to Apply New Technologies and Methods

1. Organization

Medical diagnostic and treatment facilities intending to apply new technologies and methods must have a license to operate in accordance with the laws on medical diagnosis and treatment.

2. Manpower

a) Must have sufficient doctors, nurses, midwives, technicians, and other staff to implement new technologies and methods according to the approved technical procedures as stipulated in Article 7 of this Circular.

b) The personnel implementing new technologies and methods must meet the following conditions:

- Possess a practice certificate for medical diagnosis and treatment that covers the relevant specialty corresponding to the new technology or method.

- Hold a certification or certificate of training in the new technology or method to be implemented, issued by a training institution or a technology transfer certificate from domestic or foreign medical diagnostic and treatment facilities.

- Be legally employed at the medical diagnostic and treatment facility.

Article 5. Conditions Regarding Infrastructure

Medical diagnostic and treatment facilities must ensure infrastructure in compliance with Circular No. 41/2011/TT-BYT dated November 14, 2011, issued by the Minister of Health, guiding the issuance of practice certificates for practitioners and operating licenses for medical diagnostic and treatment facilities, as well as other necessary conditions to meet the requirements for applying new technologies and methods.

Article 6. Conditions Regarding Equipment, Medicines, and Medical Supplies

Medical diagnostic and treatment facilities must have adequate equipment, medical instruments, medicines, and medical supplies permitted for circulation in Vietnam to meet the requirements of implementing new technologies and methods according to the approved technical procedures as stipulated in Article 7 of this Circular.

Article 7. Conditions Regarding Technical Procedures

1. For the application of new technologies and methods as prescribed in Clause 1 and Clause 2, Article 2 of this Circular:

Medical diagnostic and treatment facilities implementing new technologies and methods must develop technical procedures based on the framework for drafting technical procedures set out in Appendix 1 attached to this Circular and approved by the head of the medical diagnostic and treatment facility upon consultation with the Ethics Committee on Biomedical Research of the medical diagnostic and treatment facility.

2. For the application of new technologies and methods as prescribed in Clause 3, Article 2 of this Circular:

Medical diagnostic and treatment facilities must implement technical procedures already approved by the Minister of Health. In cases where the technical procedures have not been approved by the Minister of Health, the medical diagnostic and treatment facilities must develop and approve the technical procedures in accordance with Clause 1 of this Article.

Chapter III
FILES, PROCEDURES, AND AUTHORITY TO PERMIT THE APPLICATION OF NEW TECHNOLOGIES AND METHODS IN DIAGNOSIS AND TREATMENTTREATMENT FACILITY

Article 8. Application File for Pilot Implementation of New Technologies and Methods

1. A request form for pilot implementation of new technologies and methods in accordance with the model specified in Appendix 2 attached to this Circular.

2. Documentation proving legality, clinical evidence, and effectiveness in medical diagnosis and treatment of new technologies and methods:

a) For new technologies and methods as prescribed in Point b, Clause 1, Article 2 of this Circular:

- Report on the results of clinical trials of the new technology or method conducted at foreign facilities.

- Official document from the competent authority of the foreign country confirming that the new technology or method has completed safety and efficacy studies and is recommended for application. This document must be apostilled in accordance with Vietnamese law.

- Certified copy of the minutes of the review committee's decision to allow the application of the new technology or method recognized by the Ministry of Health's Bioethics Review Board or the Ministry-level Scientific Council.

- Certified copy of the certificate of recognition of the results of clinical research on the new method or technology issued by the Department of Science, Technology, and Training, Ministry of Health.

b) For new technologies and methods as prescribed in Clause 2, Article 2 of this Circular:

- Report evaluating the results regarding the safety and effectiveness of applying the technology or method by foreign medical diagnostic and treatment facilities (must include an English version and a Vietnamese translation).

- Certified copy of the official document from the competent authority of the country that has allowed the implementation of the new technology or method, apostilled in accordance with Vietnamese law.

c) For new technologies and methods as prescribed in Clause 3, Article 2 of this Circular:

- Certified copy of the official document from the competent authority that has allowed Vietnamese medical diagnostic and treatment facilities to apply the new method or technology.

- Report evaluating the results regarding the safety and effectiveness of applying the new technology or method by Vietnamese medical diagnostic and treatment facilities that have implemented the new technology or method.

3. Implementation Plan for Applying New Technologies and Methods including the main contents: description of the capabilities of the medical diagnostic and treatment facility proposing to apply new technologies and methods concerning infrastructure, human resources, medical equipment, and technical procedures to be implemented as stipulated in Articles 4, 5, 6, and 7 of this Circular; proposed service prices, economic and social benefits, and implementation plan.

4. Certified copies of practice certificates for medical diagnosis and treatment and certified copies of certificates or specialized certificates of practitioners related to the implementation of new technologies and methods. Certificates, certificates, and specialized certificates of practitioners issued by foreign institutions must be apostilled in accordance with Vietnamese law.

5. Certified copies of technology transfer contracts in cases where they are received from other organizations or individuals.

Article 9. Receiving Authority for Applications

1. The Department of Medical Examination and Treatment under the Ministry of Health:

a) Receives applications from healthcare facilities requesting to pilot new medical techniques and methods as stipulated in Point b Clause 1 and Clause 2, Article 2 of this Circular and requests to officially apply new medical techniques and methods as stipulated in Clause 1 and Clause 2, Article 2 of this Circular.

b) Receives applications from healthcare facilities under the Ministry of Health, other ministries and sectors, and private hospitals licensed by the Ministry of Health requesting to pilot new medical techniques and methods and requests to officially apply new medical techniques and methods as stipulated in Clause 3, Article 2 of this Circular.

2. Departments of Health of provinces and centrally governed cities (hereinafter referred to as Departments of Health) receive applications from healthcare facilities within their jurisdiction for cases requesting to pilot new medical techniques and methods and requests to officially apply new medical techniques and methods as stipulated in Clause 3, Article 2 of this Circular, except for healthcare facilities specified in Point b Clause 1 of this Article.

3. For healthcare facilities under the management authority of Departments of Health or health departments of ministries and sectors: When submitting applications to the Ministry of Health, they must simultaneously submit a report to the immediate superior management agency regarding the submission of the application for piloting or officially applying new medical techniques and methods.

Article 10. Procedures for Permitting Pilot Application of New Medical Techniques and Methods

1. Healthcare facilities submit one set of application documents as prescribed in Article 8 of this Circular to the receiving authority as prescribed in Article 9 of this Circular.

2. Method of submitting applications: Submit directly at the receiving authority or send via postal service.

3. Within five working days from the date of receipt of the application (based on the date recorded in the incoming document register of the receiving authority), the receiving authority must examine and determine whether the application is valid or invalid.

For invalid applications, the receiving authority must issue a notification to the healthcare facility requesting to pilot new medical techniques and methods to complete the application. The notification must specify the required supplementary documents and the necessary modifications and supplements.

Upon receiving the request for completing the application, the healthcare facility must supplement and modify according to the contents specified in the notification and resubmit to the receiving authority. The date of receipt of the modified and supplemented application is recorded on the Application Receipt Form or the Incoming Document Register of the receiving authority. If the supplemented application still does not meet the requirements, the healthcare facility must continue to perfect the application.

4. Within seven working days from the date of receipt of the valid application recorded on the Application Receipt Form or the Incoming Document Register of the receiving authority, the receiving authority must organize an assessment of the application.

In case of necessity, the head of the receiving authority decides to seek expert opinions or establish an advisory board to review the application and conclude with a minutes.

5. Within three working days from the date of receipt of the assessment report:

a) For new medical techniques and methods as stipulated in Point b Clause 1 and Clause 2, Article 2 of this Circular:

The Department of Medical Examination and Treatment submits to the Minister of Health for a decision to permit the healthcare facility to pilot new medical techniques and methods, specifying the number of patients or duration for each type of new technique or method. In case of disagreement with permitting the healthcare facility to pilot new medical techniques and methods, the Department of Medical Examination and Treatment must issue a response letter stating the reasons.

b) For new medical techniques and methods as stipulated in Clause 3, Article 2 of this Circular:

- The Minister of Health or the Director of the Department of Health decides to permit the healthcare facility to pilot new medical techniques and methods, specifying the number of patients for each type of new technique or method.

- In case of disagreement with permitting the healthcare facility to pilot new medical techniques and methods, the head of the receiving authority must issue a response letter stating the reasons.

6. After the completion of the pilot phase of new medical techniques and methods as decided by the Minister of Health or the Director of the Department of Health, the healthcare facility must submit a written report on the results of the pilot and propose whether to proceed with official implementation or not.

In case the healthcare facility proceeds with official implementation of new medical techniques and methods, it must submit the application as prescribed in Article 11 of this Circular.

Article 11. Documents for Requesting Official Application of New Techniques and Methods

After completing the pilot implementation phase, medical examination and treatment facilities prepare the report on the results of the pilot application of new techniques and methods as follows:

1. A request form for officially applying new techniques and methods according to the model prescribed in Appendix No. 3 issued together with this Circular.

2. A report on the results of piloting new techniques and methods by medical examination and treatment facilities according to the model prescribed in Appendix No. 4 issued together with this Circular.

3. The technical procedure proposed by the medical examination and treatment facility and approved in accordance with Article 7 of this Circular.

Article 12. Procedures for Permitting Official Application of New Techniques and Methods new methods

1. Medical examination and treatment facilities submit one set of documents in accordance with Article 11 of this Circular to the agency responsible for receiving documents as stipulated in Article 8 of this Circular.

2. Method of submitting applications: Submit directly at the receiving authority or send via postal service.

3. Within five working days from the date of receipt of the documents (based on the date recorded in the incoming document register of the agency receiving the documents), the agency must determine whether the documents are valid or invalid.

For invalid documents, the agency receiving the documents must issue a written notice to the medical examination and treatment facility requesting the official application of new techniques and methods to complete the documents. The notice must specify in detail the required amendments and supplements.

Upon receiving the request for completing the application, the healthcare facility must supplement and modify according to the contents specified in the notification and resubmit to the receiving authority. The date of receipt of the modified and supplemented application is recorded on the Application Receipt Form or the Incoming Document Register of the receiving authority. If the supplemented application still does not meet the requirements, the healthcare facility must continue to perfect the application.

4. Within fifteen working days from the date of receipt of the complete valid documents recorded on the Document Receipt Form or Incoming Document Register:

a) For new techniques and methods specified in Point b Clause 1, Clause 2 Article 2 of this Circular: The Director of the Department of Medical Examination and Treatment must decide to establish a specialized committee and organize the review of the results of the pilot implementation and the technical procedures proposed by the medical examination and treatment facility.

b) For new techniques and methods specified in Clause 3 Article 2 of this Circular: The Director of the Department of Medical Examination and Treatment or the Director of the Health Department must decide to establish a specialized committee and organize the review of the results of the pilot implementation and the technical procedures proposed by the medical examination and treatment facility.

5. The specialized committee established under Clause 4 of this Article includes experts in management, clinical, and paraclinical fields related to new techniques and methods. The specialized committee is responsible for reviewing the results of the pilot implementation, technical procedures, and issuing conclusions in the form of minutes.

6. Within five working days from the date of receipt of the review minutes of the specialized committee, the Minister of Health or the Director of the Health Department decides to permit the medical examination and treatment facility to officially implement the application of new techniques and methods and approve the technical procedures. In case of disagreement, a written response must be provided with specific reasons stated.

Chapter IV
IMPLEMENTING PROVISIONS

Article 13. Effective Date

This Circular takes effect from June 1, 2015.

Article 14. Cross-referencing Provisions

In cases where referenced documents in this Circular are replaced or amended, the replacement or amended documents shall apply.

Article 15. Fees for Reviewing and Permitting the Application of New Techniques and Methods in Medical Examination and Treatment

Medical examination and treatment facilities submitting documents to request the application of new techniques and methods must pay fees in accordance with the laws on fees and charges.

Article 16. Responsibility for Implementation

The Director of the Department of Medical Examination and Treatment is responsible for organizing the implementation, inspection, and evaluation of the execution of this Circular.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to promptly reflect them to the Department of Medical Examination and Treatment, Ministry of Health for consideration and resolution./.

attached hereto.

(Issued together with Circular number /TT-BYT dated month year

of the Minister of Health)

FORM OF TECHNICAL PROCEDURE FRAMEWORK

1. Number of pages: 1-3 pages

2. Font: Times New Roman. Font size: 14; left margin 3 cm, right margin: 2 cm, top margin 2.5 cm, bottom margin 2 cm

- Name of Technical Procedure font size 14, bold capital letters

- Headings are numbered in Roman numerals, bold capital letters.

- Subheadings (under Roman numerals) are numbered in Arabic numerals, regular font, bold.

3. Content: including the following parts

I. Overview/Definition

II. Indications

III. Contraindications

IV. Preparation:

1. Personnel implementing the technical procedure: doctors, nurses, technicians...

2. Equipment: name, quantity of devices, tools, consumables (standard, estimated...)

3. Patient

4. Medical records

V. Implementation Steps (including specific timeframes)

1. Document review

2. Patient check-up

3. Performing the technique: ....

………..

VI. Monitoring:

VII. Handling Complications

VIII. Notes if necessary

attached hereto to the People's Committee of the province.

(Issued together with Circular number /TT-BYT dated month year

of the Minister of Health)

PETITION FOR APPLICATION

Pilot Application of New Techniques and Methods in Medical Examination and Treatment

in diagnosis and treatment

Respectfully submitted to: Department of Medical Examination and Treatment, Ministry of Health

or Health Department of province, city...

I. Information about the facility implementing the pilot application of new techniques and methods

1. Name of medical examination and treatment facility:

2. Address:

3. Phone number: Fax number:

4. Full name of contact person:

Mobile phone number:

Email:

II. Information about new techniques and methods

1. Name of new technique/method:

2. Specialty:

After studying the Law on Medical Examination and Treatment, our medical examination and treatment facility requests the Ministry of Health/Health Department to allow the pilot application of this technique/method and guarantees that the above information is true. If incorrect, the facility will bear full responsibility under the law.

Attached documents (as stipulated in Article 8 of Circular number .../TT-BYT) include: ...

Respectfully,

APPLICATION FORMS AND REGISTRATION TABLES FOR REQUESTING ISSUANCE OF CERTIFICATES AND LICENSES AND SAMPLES OF CERTIFICATES AND LICENSES

(Issued together with Circular number /TT-BYT dated month year

of the Minister of Health)

PETITION FOR APPLICATION

Official Application of New Techniques and Methods in Medical Examination and Treatment

Respectfully submitted to: Department of Medical Examination and Treatment, Ministry of Health

or Health Department of province, city...

I. Information about the facility implementing new techniques and methods

1. Name of medical examination and treatment facility:

2. Address:

3. Phone number: Fax number:

4. Full name of contact person:

Mobile phone number:

Email:

II. Information about new techniques and methods

1. Name of new technique/method:

2. Specialty:

We have implemented the pilot application of new techniques/methods from day...month...year...to day...month...year...

After completing the pilot implementation, our medical examination and treatment facility requests the Ministry of Health/Health Department to allow the official application of this technique/method and guarantees that the above information is true. If incorrect, the facility will bear full responsibility under the law.

Attached documents (as stipulated in Article 11 of Circular number .../TT-BYT) include: ...

Respectfully,

Number of Agents

(Issued together with Circular number /TT-BYT dated month year

of the Minister of Health)

REPORT

Results of Pilot Application of New Techniques and Methods

in diagnosis and treatment

Respectfully submitted to: Department of Medical Examination and Treatment, Ministry of Health

or Health Department of province, city...

I. Information about new techniques and methods

1. Name of new technique, method:

2. Specialty

II. Implementation Results

1. Pilot implementation period: from day month year to day month year

2. Total number of cases treated: cases. Among which

- Recovered: case of illness

- Improved: case of illness

- Improved: case of illness

- No change: case of illness

- Worsened: case of illness

- Deceased: case of illness

3. Summary of cases of illness that have been carried out:

III. Difficulties and advantages