Vietnam’s medical industry is growing rapidly along with the country’s booming economy, and the country of nearly 100 million people is set to upgrade its medical infrastructure over the next decade. For now, Vietnam still relies on imported medical devices, so foreign manufacturers can expect strong growth in the next few years. Statistics show that 90% of medical device spending in Vietnam is now from foreign manufacturers. This provides manufacturers with an opportunity for rapid growth.
1. Competent institutions and core regulations
Registration of medical device products in Vietnam is supervised by the Department of Medical Equipment and Construction (DMEC) under the Ministry of Health (MOH). At present, Vietnam’s medical device registration regulations are in a transitional state. The new rules governing the registration of medical devices were issued on 8 November 2021, Decree No. 98/2021, replacing the previous Decree No. 36/2016/ND-CP, which was amended by Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP. The new rules will come into force on January 1, 2022, with a one-year transition period for Category C and D products.
2, product classification
In Viet Nam, medical instruments are any tools, chemicals, equipment, materials and software necessary to detect, prevent, diagnose and/or mitigate disease, or to replace, examine, modify or provide surgical support during examination or treatment, used individually or in combination. Under the new rules, software is considered a medical device, but not regulated. Medical devices are classified in Vietnam according to their intended use and level of risk, method of delivery and degree of intrusion into the human body. Viet Nam strictly follows GHTF guidelines for classifying devices in categories A, B, C and D from low risk to high risk. The classification guide can be found in Circular 39/2016. Devices are classified from low to high risk into one of the following:
Vietnam Medical Device Classification Table
lA (low risk, e.g. wheelchairs, bandages)
lB (low average risk, e.g. blood centrifuge, injection needle)
lC (high average risk, e.g. diagnostic X-ray equipment, ureteral stents)
lD (High risk, e.g. absorbable sutures, dental implants, rhythm regulators)
3. common summary:
Prepare registration documents: Prepare all necessary registration documents, including validation test reports, manufacturing and quality assurance documents, sales authorizations and notations, specifications and application forms. In addition, you will need to provide details and qualifications about manufacturers, agents and distributors.
Choice of registration route: There are two routes for Vietnamese medical device registration: 1) National registration or 2) reviewer evaluation. National registration applies to all medical devices exported to the country’s market. The auditor evaluated the route applicable to medical devices sold in the domestic market in Viet Nam.
Submit your application to the Vietnamese Drug Control Department: Submit your registration application and relevant documents to the Vietnamese Drug Control Department for review.
Audit and testing: The Vietnamese Department of Pharmaceutical Management will review your documents and conduct a field audit and testing of your medical device.
Obtain a Certificate of Registration: If your product is approved, the Pharmaceutical Administration Department will issue a certificate of registration.
4. lIVD classification Rules:
Extracorporeal diagnostic devices in Vietnam are classified into four categories (A to D) based on seven risk-based rules and strictly follow the ASEAN IVDD guidelines. Specific rules for the classification of in vitro diagnostic devices are set out in Part III of Appendix I of Circular 39/2016. Factors affecting risk include:
Purpose and indication of use;
Professional knowledge of medical device users;
The importance and impact of medical device information on personal and public health.
It is important to note that the procedures for registering medical devices in Vietnam are subject to update and change, especially with regard to Vietnamese national regulations and standards.
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Post time: Jun-02-2023