Chương I Nghị định 96/2023/NĐ-CP: Những quy định chung

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Decree provides detailed regulations on some Articles of the Law on Medical Examination and Treatment in respect of:

a) Issuance of license to practice medicine (hereinafter referred to as “practicing license”);

b) Issuance of license to provide medical services (hereinafter referred to as “operating license”);

c) Application of new techniques and methods, and clinical trials in healthcare;

d) Management of medical devices at health facilities;

dd) Mobilization or dispatch of health facilities to delivery medical services in case of occurrence of natural disasters, catastrophes, group-A infectious diseases or state of emergency;

e) Preconditions for healthcare operations;

g) Guidance on implementation roadmap; transition provisions on practicing license and operating license.

2. This Decree does not apply to the following operations of medical practitioners and health facilities under People's armed forces, including:

a) Practicing as medical interns, medical internship guide, issuance, re-issuance, renewal, modification, suspension or revocation of practicing license of medical practitioners;

b) Cases, conditions, application requirements and procedures of issuance, re-issuance, modification, suspension or revocation of operating license of health facilities, and templates of operating license;

c) Healthcare quality assessment and certification;

d) Classification of professional and technical expertise in healthcare.

3. Health facilities that are public administrative units shall exercise autonomy in accordance with regulations of law on autonomy.

Article 2. Definitions

1. “full-time medical practitioner” means an employee who has been granted a practicing license and has obtained registration for practice medicine for the full administrative working hours of a health facility.

2. “administrative hours” of a health facility means the length of time available for performing administrative tasks, defined and publicly announced by that health facility on the condition that it is appropriate to normal working hours prescribed by the Labor Code.

3. “opening hours” of a health facility means the length of time used for performing medical examination and treatment activities, defined and registered by that health facility, and specified in its operating license issued by a competent authority. Opening hours include administrative working hours.

4. “change in professional title” is a medical practitioner’s applying for change from a professional title to another one upon his/her satisfaction of relevant conditions, and terminating practicing of medicine under the professional title previously awarded by a competent authority.

5. “legitimate copy” means a photocopy or copy extracted from the master register by a competent authority or organization, or a certified true copy, including certified electronic copy or a copy printed by a competent authority or organization from electronic documents in national databases in respect of information stored on national databases, or a copy that has been compared with its original.

6. “not-for-profit health facility” means a health facility whose revenues earned during its operation shall not be distributed to its employees, shareholders, members or capital contributors but be used for maintaining its main operations.

7. “head of health facility” means the person who holds the position of general director or director of a health facility (including those that are public administrative units having management boards) or who is appointed to act as the head of a private health facility under the relevant enterprise's charter on operation.

A health facility’s head may not be the person in charge of professional practices of that health facility.

8. “specialty qualification" means a document certifying its holder's completion of a specialized postgraduate training course in healthcare sector in corresponding to one of the titles specified in points a, c, d, dd, e, g, h clause 1 Article 26 of the Law on Medical Examination and Treatment.

9. “scope of practice” means a range of activities which can be performed by a medical practitioner, and is specified in:

a) his/her practicing license;

b) the decision to adjust scope of practice issued by a competent authority defined in Article 28 of the Law on Medical Examination and Treatment; or

c) written permission to implement techniques given by the person in charge of professional practices of the health facility as prescribed in clause 3 Article 10 or clause 3 Article 125 of this Decree.

10. “professional department” of a health facility means a body that takes charge of performing medical examination and treatment tasks and is included in the organizational structure of that health facility. A professional department may be an institute, center, division or ward, or unit.

11. “medical device part" means a part or set of parts contributed to the composition of a medical device, used in replacement or repair aimed at ensuring or improving efficiency and capacity of medical devices used at health facilities.

12. “test equipment” means medical devices, including reagents, calibrators, control materials, instruments and other products, whether used alone or in combination, intended by the product owner, to be used in tests for the examination of specimens derived from the human body.

13. “risk management” means a competent health authority’s application of methods and professional processes to identify, evaluate and classify risks as the basis for allocating or arranging reasonable resources for inspecting, monitoring and assisting effective management of medical examination and treatment activities.