Vietnam-MOH
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1. Vietnamese Regulatory Authority
Registration of Medical Device in Vietnam is administered by the Department of Medical Equipment and Construction (DMEC) under the Ministry of Health (MOH), the main responsibilities are: to audit、approve the registration and regulation of Medical Device to ensure that Medical Devices meet the safety and efficacy requirements in the Vietnamese market.
2. Administrative Regulation
Decree No.98/2021/ND-CP – Effective January 1st,2022
Decree No.111/2021 – Amends Decree 43/2017 and update the requirement of Labeling
Circular No.05/2022 – Provide the Product List that require Registration prior to importation
Decree No. 07/2023 (EN/VN) – Extend the Validity of Import Licenses and delays the implementation of CSDT application requirements, as well as additional clarifications
3. Risk Classification
【Medical Device】
【IVD】
4. Admittance requirement
ISO 13485 Certificate
Free Sale Certificate (FSC)
5. Registration Language
English and Vietnamese
Chapter 2 Registration Flow|Timeline|Official Fee
1. Registration Flow
2. Timeline and Official Fee
Chapter 3 FAQ
Q: Does Vietnam Registration require a certificate of registration of the original country?
A: Not mandatory.
Q: Is it necessary to submit Disposable Medical Device Warranty for the registration of disposable medical devices? What should be indicated if it is a reused medical device.
A: Disposable medical device needs to submit the document “Explanation letter for single use”, reused medical device need to provide proof of after-sales service ability.
Q: Is the Vietnam certificate transferable?
A: Vietnamese certificates are not transferable.
Q: Is Vietnam a unique agent?
A: No.
Chapter 4 Certificate Template
Chapter 5 Wiselink Group Vietnam subsidiary Wiselink VN
CÓNG TY TNHH Y TÉ WISELINK is the wholly owned subsidiary of Wiselink Group in Vietnam, it has Vietnam medical equipment, cosmetics, food, health products import, distribution qualification, can be used as the manufacturer's local representative in Vietnam.
