Regulatory Affairs Update: Vietnam

Vietnam: MoH Shares New Draft Law on Medical Devices in Vietnam

From a conference attended by Andaman Vietnam team on July 11, 2024, the Ministry of Health announced that they are preparing to submit to the Government a draft Law on Medical Devices by December 2024.

Currently, medical devices in Vietnam are under the management of some valid regulations such as: Decree 98/2021/ND-CP; Decree 07/2023/ND-CP and Decree 96/2023/ND-CP. In comparison with these regulations, the proposed draft of the MoH regulates more specific requirements. Some of the key highlights are mentioned below:

  • This Law stipulates the policy on medical devices management: development of the manufacturing industry; classification; clinical trials; registration, circulation, business, services, information, advertising, recall; management and use of medical devices in medical facilities and the community.
  • Several definitions in the field of medical devices, especially in vitro medical devices, spare parts, business unit of medical devices, renovative medical devices, refurbished medical devices, and repairing medical devices are added and clarified.
  • The Ministry of Health will detail the Medical Device Nomenclature, and Medical Device Identification Code.
  • Prohibited acts in the field of medical devices are listed.
  • Regarding medical device circulation registration, class A medical devices will undergo procedures for declaring applicable standards and will be managed by the provincial Department of Health; class B, C, and D medical devices will be registered for circulation and managed by the specialized medical device management agency under the Ministry of Health (Infrastructure and Medical Device Administration – IMDA).
  • The circulation license of a medical device is valid indefinitely; for the circulation license issued according to regulations in emergency cases to serve the prevention and control of epidemics, overcoming the consequences of natural disasters and catastrophes, and is issued according to regulations for refurbished medical equipment, the Minister of Health will decide on the specific duration, but not exceeding 5 years. The license holder must pay the maintenance fee for the circulation license before December 31 of each year. If the fee is not paid after that time, the validity of the circulation license will be suspended, and the products will not be circulated on the market during this period. The circulation license will continue to be valid after the maintenance fee is paid. The circulation license will expire if the maintenance fee is not paid for 2 consecutive years.
  • The license holder must establish a quality management system suitable for the product and maintain effective operations; and report any changes in the design, materials, manufacturing processes, scope of application, and method of use of registered medical devices of Class B, C and D that may affect the safety, quality and effectiveness of the medical device; any adverse incidents that may affect the safety, quality and effectiveness of the medical device; and report annually before March 31 of the following year on the import and trading situation of medical devices.
  • Requirements for medical device distributors are also specified in the Law on Medical Devices.

The draft Law on Medical Equipment is still in the process of being finalized with the expected goal of perfecting the institution and improving the efficiency of medical device management. The Ministry of Health still hopes to receive constructive comments from relevant companies and units.

For more details on the regulation, please refer to this file shared during MOH conference: 

30. Draft of Law on Medical Device.pdf (in Vietnamese).

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