Vietnam to Adopt ASEAN Documentation Standards for Medical Device Approvals

In a long-anticipated move toward tightening and streamlining approval requirements for medical devices, Vietnam’s Ministry of Health announced in May that approval of Class B, C, and D medical devices will soon be required to use the ASEAN Common Submission Dossier Template (CSDT).

The template is a collection of information and requirements that allows a device manufacturer to provide the same body of product registration documentation to various regulatory authorities of the ASEAN member states. Vietnam first signaled in 2019 that it would require use of the template, as part of a series of moves designed to limit risks to consumers of the rapidly expanding medical device industry in Vietnam.

The requirement to use the CSDT goes into effect in January 2022, but manufacturers can employ the format before that time, making the approval process in Vietnam easier for device makers who already employ the template for use in other ASEAN markets.

Manufacturers will also be able to present the majority of their applications in English, rather than in Vietnamese, as they have in the past. But they will need to prove that their devices meet computer and internet security standards.