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Medical Device Management in Vietnam

Vietnam’s medical device management is overseen by the Ministry of Health (MOH) and its subordinate agency, the Department of Medical Equipment and Construction (DMEC). The DMEC is responsible for regulating and controlling medical devices in Vietnam to ensure their safety, quality, and efficacy. Some of the areas covered by the Vietnamese’s medical device management regime include:

  1. Registration and Licensing: All medical devices intended for sale or use in Vietnam must undergo registration with the DMEC. The registration process involves submitting detailed information about the device, including its technical specifications, manufacturing processes, and clinical data. After successful registration, a license is issued for the device to be marketed and distributed in Vietnam.
  2. Classification: Medical devices in Vietnam are classified into four categories (A, B, C, and D) based on their risk levels, with Class A devices being of low risk and Class D devices being of highest risk. The classification determines the requirements for registration and the level of scrutiny during the review process. Higher-risk devices, such as implantable devices or those used for life support, require more extensive documentation and evaluation.
  3. Quality Standards: Medical devices in Vietnam must meet the relevant national and international standards. The DMEC follows a risk-based approach, where higher-risk devices are subject to more stringent requirements. The Vietnamese standards for medical devices align with international standards, such as ISO 13485 (Quality Management System for Medical Devices)..
  4. Post-Market Surveillance: The DMEC monitors medical devices after they have been approved and placed on the market. Post-market surveillance activities include inspections, sampling, testing, and adverse event reporting. Manufacturers and distributors are required to report any adverse events or product defects to the DMEC, and they are responsible for taking appropriate corrective actions in accordance with the ASEAN Medical Device Directive.
  5. Import and Distribution: Companies wishing to import and distribute medical devices in Vietnam must obtain an import license from the MOH according to the corresponding Class of medical device sought to be imported. Authorized distributors must also comply with the DMEC’s regulations regarding storage, handling, and distribution of medical devices. The DMEC maintains a list of licensed importers and distributors, and it regularly inspects their facilities to ensure compliance.
  6. Regulatory Updates: Vietnam’s medical device regulations are periodically updated to align with international standards and best practices. It is essential for manufacturers, importers, and distributors to stay updated with the latest regulations and comply with any changes introduced by the DMEC.

It is important to note that while this information provides an overview of Vietnam’s medical device management, specific requirements and processes may vary depending on the type of device and its risk classification. Therefore, it is advisable to consult the official guidelines and regulations provided by the Ministry of Health and the Medical Device Administration such as Decree Nos. 98/2021/ND-CP dated 8 November 2021, Decree Nos. 07/2023/ND-CP dated 3 March 2023, Circular No. 05/2022/TT-BYT dated 01 August 2022 and Circular No. 30/2015/TT-BYT dated 12 October 2015 as well as the ASEAN Medical Device Directive for details and up-to-date information.