Vietnam Medical Device Regulatory Authority
The core regulatory framework for medical devices in Vietnam is based on Decree No. 98/2021/ND-CP issued by the Ministry of Health, along with subsequent supplementary guidance. This framework implements a relatively simplified registration process for Class A and Class B medical devices. In practice, while the process is simplified, attention must still be paid to the completeness and accuracy of documentation to avoid delays in approval due to minor omissions. The registration of Class C and Class D medical devices differs fundamentally in nature, process, and depth from that of Class A and Class B devices. The core requirement is that applicants must submit complete registration dossiers directly to the medical device regulatory authority under the Ministry of Health (MOH) and undergo a rigorous technical review.
Regulatory Authority Official Website Link:https://imda.moh.gov.vn/web/guest/trangchu
Database Link: https://imda.moh.gov.vn/web/guest/van-ban-cong-bo
Regulatory Framework
- Decree No. 98/2021/ND-CP – Effective from January 1, 2022
- Decree No. 111/2021 – Amending Decree No. 43/2017 and updating labeling requirements
- Circular No. 05/2022 – Providing the list of products requiring registration prior to importation
- Decree No. 07/2023 (EN/VN) – Extending the validity of import permits, delaying the implementation of CSDT dossier requirements, and providing other instructions
Risk Classification of Medical Devices and IVD Products
1. Medical Devices
2. IVD
Registration Basis
Vietnamese regulations do not require prior registration of products in other countries as a prerequisite for market access. However, regardless of the risk classification level of the medical device, a Free Sales Certificate (FSC) must be provided as a mandatory document when submitting a registration application.
Authorized Representative
According to Vietnamese regulations, the Marketing Authorization (MA) for a medical device must be held by a locally incorporated company legally registered in Vietnam. Foreign manufacturers must appoint such a local company as their MAH (Marketing Authorization Holder), which shall be fully responsible for the product registration application and all matters with the regulatory authorities.
Admission Prerequisites
Language Requirements for Registration
English + Vietnamese
Registration Process, Timeline and Official Fees
1. Registration Process
2. Registration Timeline and Official Fees
Packaging Requirements
IFU (Instructions for Use), packaging, and labels must be provided in Vietnamese.
