The Class C medical device registration process with the Vietnam Ministry of Health (MOH) typically takes between 10 to 90 days, depending on the complexity of the application and MOH’s workload.

Registering a Class C medical device in Vietnam requires submission through the Ministry of Health (MOH) DMEC online system. The process involves classification, document preparation, submission, and approval.

As per Decree 98/2021/ND-CP, Class C medical device registration in Vietnam is valid indefinitely unless there are changes to the device or regulatory updates that require re-evaluation. However, companies must comply with post-market obligations, reporting requirements, and potential re-registration conditions in certain cases.

Once a Class C medical device is successfully registered with Vietnam’s Ministry of Health (MOH), the manufacturer and local authorized representative (LAR) must comply with post-market surveillance (PMS), reporting obligations, and regulatory maintenance to keep the registration valid.

Before submitting an application for Class C medical device registration with Vietnam’s Ministry of Health (MOH), thorough preparation is essential to avoid delays, ensure compliance, and streamline approval.

Once your Class C medical device registration is approved by Vietnam’s Ministry of Health (MOH), you must comply with post-market requirements to maintain the validity of your registration and ensure legal market entry.

Class C medical devices in Vietnam must comply with local and international standards as required by the Ministry of Health (MOH) - Department of Medical Equipment and Construction (DMEC). The registration follows Circular 39/2016/TT-BYT, which aligns with the ASEAN Medical Device Directive (AMDD).

Class C medical devices in Vietnam must meet the technical documentation requirements outlined in Circular 39/2016/TT-BYT, which aligns with the ASEAN Medical Device Directive (AMDD). Below is a detailed breakdown of the necessary technical documents.