On August 16, 2024, Vietnam introduced new guidance allowing the update of specific documents related to medical device registration facilities on the IMDA website during the regulatory review process.
This guidance permits updates for two types of documents related to changes in registration facilities.
1. Updating documents related to changes in registration facility information
- When changing the name, address, or legal representative of the registration facility, a written change request can
be submitted along with the business registration certificate of the registration facility that includes the updated
information.
2. Updating documents related to the validity of legal documents
- Documents related to the validity of legal documents (e.g., ISO 13485 certificates, authorization letters from medical
device owners, circulation certificates (Certificate of Free Sale) for imported medical devices) can be updated by
attaching supporting documents.
- If these documents are not in English or Vietnamese, they must be translated into Vietnamese and certified
according to local provisions.
For more information, please refer to the attached file below.
If you have any questions about medical device,
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