Decree No. 87/2011/ND-CP detailing and guiding the implementation of certain provisions of the Law on Medical Examination and Treatment. 87/2011/NĐ-CP

✦ 智能摘要

Decree No. 87/2011/ND-CP details and guides the implementation of certain provisions of the Law on Medical Examination and Treatment regarding the organization of medical examination and treatment facilities, issuance of operating licenses, practice certificates, quality management standards, and quality certification organizations. It applies to medical examination and treatment facilities under the State and military, as well as practitioners at these facilities.

适用范围

Medical examination and treatment facilities under the State and military; practitioners at these facilities.

要点

Organizations and individuals conducting medical examination and treatment activities must follow the organizational forms of medical examination and treatment facilities such as hospitals, clinics, midwifery houses, commune health stations, etc. (Article 3)
State-owned medical examination and treatment facilities need to complete the issuance of operating licenses according to the timeline from 2013 to 2015 (Article 5 and Article 6)
Practitioners at State-owned medical examination and treatment facilities need to complete the issuance of practice certificates according to the timeline from 2013 to 2015 (Article 7 and Article 8)
Medical examination and treatment facilities must meet national technical standards for infrastructure and medical equipment to be issued operating licenses (Article 9)
Quality certification organizations for medical examination and treatment facilities may be public service units, enterprises, or foreign branches in Vietnam and must meet specific conditions (Article 13)

🌐 本文件的社会影响

Positive impact: Ensuring the quality of medical examination and treatment through the application of quality management standards and quality certification organizations.
Negative impact: May cause difficulties for private healthcare facilities during the transition to the new model.
Balance: The level of support from the State for State-owned medical examination and treatment facilities helps ensure stability during the transition process.

❓ 常见问题

Why is it necessary to issue operating licenses for medical examination and treatment facilities?

To ensure quality and safety in healthcare, as well as compliance with national technical standards for infrastructure and medical equipment.

What is the validity period for issuing operating licenses for State-owned medical examination and treatment facilities?

State-owned medical examination and treatment facilities need to complete the issuance of operating licenses according to the timeline from 2013 to 2015.

What is the validity period for practitioners at State-owned medical examination and treatment facilities to obtain practice certificates?

Practitioners need to complete the issuance of practice certificates according to the timeline from 2013 to 2015.

What standards must medical examination and treatment facilities meet to obtain operating licenses?

Medical examination and treatment facilities must meet national technical standards for infrastructure and medical equipment and other conditions stipulated in Article 43 of the Law on Medical Examination and Treatment.

What types can quality certification organizations for medical examination and treatment facilities be?

Quality certification organizations for medical examination and treatment facilities may be public service units, enterprises, or foreign branches in Vietnam.

全文

DECREE

Detailed regulations and guidance on implementation of certain provisions of the Medical Examination and Treatment Law

_______________________________

THE GOVERNMENT

Pursuant to the Law on Organization of the Government dated December 25, 2001;

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

Considering the proposal of the Minister of Health,

DECREE:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree specifies the implementation of Clause 6 Article 25, Article 41, Clause 6 Article 44, and Clause 3 Article 51 of the Medical Examination and Treatment Law regarding:

1. The organizational forms of medical examination and treatment facilities; the organizational forms of medical examination and treatment facilities within the military.

2. The timeline for issuing permits to operate for state-owned medical examination and treatment facilities.

3. The timeline for issuing practice certificates for practitioners currently involved in medical examinations and treatments at state-owned medical examination and treatment facilities.

4. National technical standards, quality management standards, and quality certification organizations for medical examination and treatment facilities.

Article 2. Applicability

This Decree applies to domestic agencies, organizations, and individuals, including medical examination and treatment facilities under the police and military (hereinafter referred to collectively as organizations and individuals), foreign organizations and individuals conducting activities related to medical examinations and treatments in Vietnam.

Chapter II

ORGANIZATIONAL FORMS OF MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 3. Organizational forms of medical examination and treatment facilities

1. Organizations and individuals conducting medical examination and treatment activities must follow the organizational forms of medical examination and treatment facilities as follows:

a) Hospitals including general hospitals, specialized hospitals, traditional medicine hospitals;

b) Medical forensic facilities;

c) Outpatient clinics including general outpatient clinics, specialized outpatient clinics, family doctor clinics, traditional Chinese medicine clinics, and infirmaries;

d) Maternity homes;

đ) Diagnostic centers including imaging and laboratory departments;

e) Health service facilities including injection (injection), bandage changing, pulse counting, temperature measurement, blood pressure measurement services; home health care service facilities; emergency service facilities, patient transportation support services within the country and abroad; optical service facilities; denture service facilities;

g) Commune health stations; health stations of agencies, units, and organizations.

2. The Minister of Health shall specify detailed conditions for issuing permits to operate for each organizational form of medical examination and treatment facilities as stipulated in Clause 1 of this Article.

Article 4. Organizational forms of medical examination and treatment facilities within the military

1. Within the military, the implementation of medical examinations and treatments must follow one of the organizational forms of medical examination and treatment facilities as specified in Clause 1 of Article 3 of this Decree. In cases where it is necessary to meet the requirements of medical examinations and treatments under wartime conditions, the Minister of Defense shall decide to establish other suitable organizational forms of medical examinations and treatments.

2. The Minister of Defense shall specify detailed conditions for issuing permits to operate for organizational forms of medical examination and treatment facilities under their jurisdiction as stipulated in Clause 1 of this Article.

Chapter III

TIMELINE FOR ISSUING PERMITS TO OPERATE FOR STATE-OWNED MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 5. Timeline for issuing permits to operate medical examination and treatment facilities for state-owned medical examination and treatment facilities under the jurisdiction of the Ministry of Health and provincial-level city Departments of Health

State-owned medical examination and treatment facilities under the jurisdiction of the Ministry of Health and provincial-level city Departments of Health (hereinafter referred to as provinces) that are operating at the time when the Medical Examination and Treatment Law comes into effect and meet all conditions stipulated in Article 43 of the Medical Examination and Treatment Law shall be issued permits to operate according to the following timeline:

1. Complete the issuance of permits to operate for state-owned medical examination and treatment facilities under the organizational form specified in Point a Clause 1 of Article 3 of this Decree before December 31, 2013.

2. Complete the issuance of permits to operate for state-owned medical examination and treatment facilities under the organizational forms specified in Points b, c, and d Clause 1 of Article 3 of this Decree before December 31, 2014.

3. Complete the issuance of permits to operate for state-owned medical examination and treatment facilities under the organizational forms specified in Points đ, e, and g Clause 1 of Article 3 of this Decree before December 31, 2015.

Article 6. Implementation schedule for issuing operating permits for medical examination and treatment facilities under the authority of the Ministry of National Defense to issue such permits

Medical examination and treatment facilities under the authority of the Ministry of National Defense to issue operating permits that are in operation at the time this Law on Medical Examination and Treatment takes effect, and which meet all conditions stipulated in Article 43 of the Law on Medical Examination and Treatment shall be issued operating permits according to the following schedule:

1. Complete the issuance of operating permits for medical examination and treatment facilities under the organizational forms specified in points a, b, c, and d of Clause 1, Article 3 of this Decree before December 31, 2014.

2. Complete the issuance of operating permits for medical examination and treatment facilities under the organizational forms specified in points đ, e, and g of Clause 1, Article 3 of this Decree before December 31, 2015.

3. The Minister of National Defense shall specify in detail the issuance of operating permits for medical examination and treatment facilities under the organizational forms specified in Clause 1, Article 4 of this Decree.

Chapter IV

IMPLEMENTATION SCHEDULE FOR ISSUING PRACTICE CERTIFICATES FOR MEDICAL PROFESSIONALS OF THE STATE

Article 7. Implementation schedule for issuing practice certificates for medical professionals working at state-owned medical examination and treatment facilities under the authority of the Ministry of Health and provincial Health Departments to issue such certificates

Medical professionals currently practicing at state-owned medical examination and treatment facilities under the authority of the Ministry of Health and provincial Health Departments to issue practice certificates at the time this Law on Medical Examination and Treatment takes effect, and who meet the conditions stipulated in Articles 18 and 19 of the Law on Medical Examination and Treatment shall be issued practice certificates according to the following schedule:

1. Complete the issuance of practice certificates for medical professionals working at state-owned medical examination and treatment facilities under the organizational form specified in point a of Clause 1, Article 3 of this Decree before December 31, 2013.

2. Complete the issuance of practice certificates for medical professionals working at state-owned medical examination and treatment facilities under the organizational forms specified in points b, c, and d of Clause 1, Article 3 of this Decree before December 31, 2014.

3. Complete the issuance of practice certificates for medical professionals working at state-owned medical examination and treatment facilities under the organizational forms specified in points đ, e, and g of Clause 1, Article 3 of this Decree before December 31, 2015.

Article 8. Implementation schedule for issuing practice certificates for medical professionals working at medical examination and treatment facilities under the management authority of the Ministry of National Defense

Medical professionals currently practicing at medical examination and treatment facilities under the authority of the Ministry of National Defense to issue practice certificates at the time this Law on Medical Examination and Treatment takes effect, and who meet the conditions stipulated in Articles 18 and 19 of the Law on Medical Examination and Treatment shall be issued practice certificates according to the following schedule:

1. Complete the issuance of practice certificates for medical professionals working at medical examination and treatment facilities under the organizational forms specified in points a, b, c, and d of Clause 1, Article 3 of this Decree before December 31, 2014.

2. Complete the issuance of practice certificates for medical professionals working at medical examination and treatment facilities under the organizational forms specified in points đ, e, and g of Clause 1, Article 3 of this Decree before December 31, 2015.

3. The Minister of National Defense shall specify in detail the issuance of practice certificates for medical professionals working at medical examination and treatment facilities under the organizational forms specified in Clause 1, Article 4 of this Decree.

Chapter V

NATIONAL TECHNICAL REGULATIONS, QUALITY MANAGEMENT STANDARDS AND QUALITY CERTIFICATION ORGANIZATION FOR MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 9. National technical standards for medical examination and treatment facilities

1. National technical standards for medical examination and treatment facilities are regulations concerning physical infrastructure and medical equipment suitable for each organizational form of medical examination and treatment facilities.

2. Medical examination and treatment facilities shall only be granted operating licenses under Article 44 of the Law on Medical Examination and Treatment when they meet the following conditions:

a) Complying with all provisions of national technical standards for medical examination and treatment facilities as stipulated in Clause 1 of this Article;

b) Having sufficient practitioners appropriate to their scope of specialized activities as guided by the Ministry of Health;

c) Other conditions as prescribed in Article 43 of the Law on Medical Examination and Treatment.

3. The Minister of Health shall promulgate national technical standards for medical examination and treatment facilities in accordance with current regulations. During the period before such national technical standards are promulgated, the Minister of Health shall specify specific conditions regarding physical infrastructure and medical equipment suitable for each organizational form of medical examination and treatment facilities.

Article 10. Standards and Recognition of Quality Management Standards for Medical Examination and Treatment Facilities

1. Quality management standards for medical examination and treatment facilities shall be implemented according to the provisions of Clause 1 of Article 50 of the Law on Medical Examination and Treatment.

2. The Minister of Health shall recognize certain international and foreign standards on quality management for medical examination and treatment facilities for application in Vietnam.

3. The Minister of Health shall stipulate criteria, documentation, and procedures for recognizing other standards, except those already recognized by the Ministry of Health under Clause 2 of this Article, concerning quality management for medical examination and treatment facilities.

4. It is encouraged that medical examination and treatment facilities which have been granted operating licenses apply the quality management standards stipulated in Clause 1 of this Article to improve the quality of medical examination and treatment.

Article 11. Organization of Quality Certification for Medical Examination and Treatment Facilities

1. Organizations for quality certification of medical examination and treatment facilities include:

c) Pharmacy departments of medical examination and treatment facilities; vaccine and medicine storage warehouses of expanded immunization facilities.

b) Enterprises;

c) Branches of foreign certification organizations in Vietnam.

2. The establishment of organizations for quality certification of medical examination and treatment facilities shall be carried out as follows:

a) Organizations for quality certification of medical examination and treatment facilities are public service units established in accordance with Decree No. 83/2006/ND-CP dated August 17, 2006 of the Government on the procedures and formalities for establishing, restructuring, and dissolving administrative and state-owned public service organizations.

b) Organizations for quality certification of medical examination and treatment facilities are enterprises established under the Enterprise Law.

c) Organizations for quality certification of medical examination and treatment facilities are branches of foreign organizations established in Vietnam under the Investment Law.

Article 12. Functions and Tasks of Organizations for Quality Certification of Medical Examination and Treatment Facilities

1. Advising and guiding medical examination and treatment facilities to apply quality management standards to enhance the quality of medical examination and treatment.

2. Issuing certificates of quality validity for medical examination and treatment facilities after assessing compliance with quality management standards, or notifying non-renewal of quality certificates if such facilities fail to maintain the certified quality management standards.

3. Supervising facilities that have been issued quality certificates to ensure maintenance of the quality of medical examination and treatment in accordance with the certified quality management standards.

Article 13. Conditions for the operation of quality certification organizations for medical examination and treatment facilities

1. The document confirming the establishment of a quality certification organization for medical examination and treatment facilities shall be one of the following documents:

a) Decision on establishment by the competent state agency for a quality certification organization for medical examination and treatment facilities that is a public service unit;

b) Business registration certificate for a quality certification organization for medical examination and treatment facilities that is a business;

c) Investment certificate for a foreign quality certification organization for medical examination and treatment facilities that is a branch in Vietnam.

2. The organizational structure must be organized in accordance with the functions and tasks of the quality certification organization for medical examination and treatment facilities, including the following departments:

a) Technical department;

b) Information department;

c) Database management department;

d) Other departments.

3. The human resources team must meet the functions and tasks and be suitable to the organizational structure of the quality certification organization for medical examination and treatment facilities, including the following conditions:

a) The director or deputy director in charge of technical matters must have at least three years of work experience in medical examination and treatment facilities or in state agencies directly managing such facilities under health administration, and hold a training certificate in medical examination and treatment quality management issued by institutions authorized to provide such training;

b) The technical department of the quality certification organization for medical examination and treatment facilities must include at least five full-time assessors who are doctors, pharmacists, university-trained nurses, engineers, or medical equipment technicians, construction engineers, or architects with at least three years of work experience in medical examination and treatment facilities or in state agencies directly managing such facilities under health administration.

4. Registration for standard conformity certification activities with the competent state agency according to the provisions of the law.

Article 14. Principles of operation for quality certification organizations for medical examination and treatment facilities

1. Only permitted to operate after meeting all conditions stipulated in Article 13 of this Decree.

2. Ensuring compliance with the provisions of Clause 1 and 2 of Article 51 of the Medical Examination and Treatment Law.

3. Quality certification must ensure compliance with recognized quality management standards by the Ministry of Health.

4. Evaluation and quality certification must be conducted voluntarily based on service contracts with medical examination and treatment facilities.

5. Securing information collected during the quality certification process.

6. Periodic or ad hoc reporting to the competent health administration agency upon request and being subject to inspection and audit by the competent health administration agency.

Chapter VI

IMPLEMENTING PROVISIONS

Article 15. Transitional Provisions

1. Private medical examination and treatment facilities that have been granted a certificate of eligibility to practice private medicine in accordance with the Private Practice of Medicine and Pharmacy Ordinance and which remain valid until or after December 31, 2010, may continue to operate medical examinations and treatments until they obtain a license to operate in accordance with the Medical Examination and Treatment Law before December 31, 2012.

2. Individuals practicing private medical examinations and treatments who have been granted a practice certificate to head private medical examination and treatment facilities in accordance with the Private Practice of Medicine and Pharmacy Ordinance and which remain valid until or after December 31, 2010, may continue to practice medical examinations and treatments until they obtain a practice certificate for medical examination and treatment in accordance with the Medical Examination and Treatment Law before December 31, 2012.

3. Individuals currently practicing private medical examinations and treatments in accordance with the Private Practice of Medicine and Pharmacy Ordinance may continue their practice until they obtain a practice certificate for medical examination and treatment in accordance with the Medical Examination and Treatment Law before December 31, 2012.

Article 16. Effective Date

1. This Decree takes effect from November 15, 2011.

2. Decree No. 103/2003/NĐ-CP dated September 12, 2003 of the Government detailing the implementation of certain provisions of the Private Practice of Medicine and Pharmacy Ordinance ceases to be effective from November 15, 2011.

Article 17. Responsibility for Implementation

1. The Minister of Health and the Minister of National Defense are responsible for guiding the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees directly under the central government shall be responsible for enforcing this Decree./.

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87/2011/NĐ-CP

Decree No. 87/2011/ND-CP detailing and guiding the implementation of certain provisions of the Law on Medical Examination and Treatment.

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Tiếng Việt Nghị định số 87/2011/NĐ-CP Quy định chi tiết và hướng dẫn thi hành một số điều của Luật Khám bệnh, chữa bệnh 한국어 법률 제87/2011/시행령-CP는 진료 및 치료에 관한 법률 일부 조항의 세부 규정과 이행 지침을 정하는 것임 中文令第87/2011/ND-CP详细规定并指导实施《医疗卫生法》中的一些条款