On December 30, 2023, the Government issued Decree 96/2023/ND-CP to update detailed regulations on several articles in the Law on Medical Examination and Treatment 2023 and amend some contents of Decree 98 /2021/ND-CP on medical equipment management. Viet An Law Firm will present the outstanding new features of Decree 96/2023/ND-CP in the article below.
The Decree details several articles of the Law on Medical Examination and Treatment regarding:
A new point in this Decree is to change the form of granting a “practicing certificate” to a “practicing license” for medical examination and treatment. Conditions for granting practice licenses corresponding to each title of doctor, nurse, etc. are specified in Article 8.
In Article 3 of Decree 96/2023/ND-CP, the regulations on time as a condition for granting a practice license have changed compared to the provisions in Article 24 of the Law on Medical Examination and Treatment 2009, which shortens the practice time as follows:
| Title | Law on Medical Examination and Treatment 2009 | Decree 96/2023/ND-CP |
| Doctor | 18 months | 12 months |
| Medico | 12 months | 09 months |
| Midwives | 09 months | 06 months |
| Nursing | 09 months | 06 months |
Also in Article 3, Decree 96 has added the medical examination and treatment practice time of new positions such as 6 months for the clinical nutritionist position, 6 months for the outpatient emergency paramedic position, and 9 months for clinical psychology positions.
Documents for new issuance, re-issuance, extension, and adjustment of professional licenses in this Decree are also reduced and simplified, in which, criminal records have been removed from the dossier, replacing personal records with a self-narrative curriculum vitae without confirmation by the commune-level People’s Committee.
In Article 14, for professional titles such as doctor, nurse, midwife, medical technician, clinical nutritionist, outpatient paramedic, and clinical psychologist, the application file for a new grant requires a practice license in the case of a person applying for a practice license for the first time as prescribed in Point a, Clause 1, Article 30 of the Law on Medical Examination and Treatment and in the cases specified in Point dd, Clause 1, Article 13 of this Decree including:
An amendment and supplement to Decree 96/2023/ND-CP compared to Decree 109/2016/ND-CP regulating the issuance of practice certificates to practitioners and operating licenses for medical examination and treatment facilities, as amended and supplemented by Decree 155/2018/ND-CP on general conditions of medical examination and treatment facilities are shown in the following table:
| Criteria | Decree 96/2023/ND-CP | Decree 109/2016/ND-CP |
| Infrastructure | Have a fixed location that meets the provisions of law on load-bearing safety, fire prevention and fighting, infection control, environmental protection, and radiation safety (if any); b Ensure adequate electricity and water to serve the operations of medical examination and treatment facilities. There are signs, diagrams, and signs leading to faculties, departments, and professional and administrative departments. | Have a fixed location (except for mobile medical examination and treatment organizations). Ensure radiation and room safety conditions during fire fighting according to the provisions of the law. A sterilization area must be arranged to process reused medical instruments, except in cases where there are no instruments that need to be re-sterilized or there is a contract with another medical facility to sterilize the instruments. |
| Medical equipment | Have medical equipment consistent with the list of technical expertise and scope of registered activities. | There is enough medical equipment suitable to the scope of professional activities of the facility. |
| Organization
Personnel |
There must be enough clinical and paraclinical examination departments, human resources, and necessary medical equipment to examine and detect health status according to health standards and a health examination form is issued along with the requirements. Medical examination guidance document. | Each medical examination and treatment facility must have a person responsible for technical expertise. In addition to the person responsible for the technical expertise of the medical examination and treatment facility, he or she must have a practicing certificate and may only perform medical examination and treatment within the scope of assigned work. |
| Health examination facility | There are enough clinical and paraclinical examination departments, human resources, and medical equipment necessary to examine and detect health status according to health standards and a health examination form is issued along with the requirements. written instructions for health examination;
|
Has been granted an operating license according to the provisions of law. There must be enough clinical and paraclinical examination departments, human resources, and necessary medical equipment to examine and detect health status according to health standards and a health examination form is issued along with the requirements. Written instructions for health examination according to the provisions of law. |
Conditions for performing remote medical examination and treatment are specified in Clause 1, Article 87 of Decree 96/2023/ND-CP as follows:
The scope of remote medical examination and treatment is as prescribed in Point a, Clause 1, Article 80 of the Law on Medical Examination and Treatment. For remote medical examination and treatment, the medical examination and treatment facility must meet the conditions specified in Clause 1, Article 87 and carry out procedures for declaring eligibility to perform remote medical examination and treatment as prescribed in Clause 2, Clause 3, Article 87 of this Decree. In case of piloting remote medical examination and treatment for diseases and conditions that are not on the prescribed list, it must be submitted to the operating licensing agency for consideration and approval.
Decree 96/2023/ND-CP also regulates the order related to the application of new techniques and new methods in medical examination and treatment according to the Law on Medical Examination and Treatment 2023, specifically in Article 96 as follows :
Step 1. When some techniques or methods are not included in the list of technical expertise issued by the Minister of Health, the medical examination and treatment facility applies to identify new techniques and methods for the Ministry of Health.
Step 2. After receiving the dossier, the Ministry of Health returns to the facility requesting the determination of new techniques and new methods in the dossier receipt form according to Form 0 2 Appendix I of this Decree.
Step 3. In case there is no request to amend or supplement the dossier, the dossier-receiving agency will respond in writing within 30 days from the date recorded on the dossier receipt, which must clearly state the new technique or new method that the establishment proposes to identify falls into one of the following cases:
Step 4. Within 60 days from the date of receipt of the documents specified in Point c, Clause 4 of this Article, the Ministry of Health is responsible for approving the technical process of new techniques and new methods; Approving economic and technical norms of new techniques and new methods; Approve prices of new techniques and new methods; Classification of new techniques, new methods; Issue documents allowing medical examination and treatment facilities to implement new techniques and new methods.
Step 5. After the Ministry of Health has approved the technical process and technical classification, other medical examination and treatment facilities must follow the following process:
Clients who need advice on legal regulations on medical examination and treatment, civil law, criminal law, and related amended decrees, please contact Viet An Law Firm for the best support.
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