The registration timeline for Class C medical devices in Vietnam depends on the completeness of the application, MOH workload, and potential requests for additional information.

To apply for Class C medical device registration with Vietnam’s Ministry of Health (MOH), you must meet several legal, technical, and regulatory conditions. These conditions ensure compliance with Circular 39/2016/TT-BYT, which follows the ASEAN Medical Device Directive (AMDD).

To register a Class C medical device in Vietnam, you must submit an application to the Ministry of Health (MOH) - Department of Medical Equipment and Construction (DMEC). The registration follows Circular 39/2016/TT-BYT, in line with the ASEAN Medical Device Directive (AMDD).

Class C medical device registration with Vietnam’s Ministry of Health (MOH) follows the requirements outlined in Circular 39/2016/TT-BYT, which aligns with the ASEAN Medical Device Directive (AMDD). Below is a detailed list of required materials and how to prepare the application documents.

Vietnam’s Ministry of Health (MOH) regulates Class C medical devices under Circular 39/2016/TT-BYT, aligned with the ASEAN Medical Device Directive (AMDD). Below is a complete guide on the procedures, required materials, and key considerations for registration.

To register a Class C medical device in Vietnam, you must submit your application through the Vietnam Ministry of Health (MOH) - Department of Medical Equipment and Construction (DMEC) Portal.

​Registering a Class C medical device with the Vietnam Ministry of Health (MOH) involves specific fees and processing times.

The LAR must be a legally registered company in Vietnam with authorization to distribute medical devices.