David Vo

General Manager

Asia Actual VietNam

“This regulatory change reflects the MoH’s efforts to facilitate the registration process and reduce administrative burdens.”

About the Author

David has over 10 years of experience in the medical device industry, specializing in in vitro diagnostics (IVDs) and regulatory compliance in Vietnam. Since joining Asia Actual, he has focused on consulting, importing, and managing distribution channels, offering in-country representation and post-market surveillance support for multinational clients.

To learn more about David and our other medical device regulatory experts across Asia, visit Our Team page.

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Sources and Links

Example of Updated Legal Document
updated legal document 16Aug2024

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VietNam Allows Amendments to Registration Applications

Published on: September 16th, 2024

On August 16th, 2024, the VietNam Ministry of Health (MoH) introduced new regulatory guidance allowing for certain documents in the VietNam registration application to be updated during the regulatory review process. This is a welcome move by the Vietnamese MoH that should serve to decrease the number of application insufficiencies due to expired documentation during the longer than planned application review times.

The guidance identifies two types of documents that can be updated during the medical device application review process.

1. Submission of Updated Registration Information:

Companies can now submit requests to change registration details, such as the name or address of the registration facility or the legal representative. These changes must be fully confirmed by the registration facility and supported by appropriate business registration certificates.

2. Submission of Documents Related to Legal Validity

The MoH allows submissions of documents under evaluation concerning the validity of legal documents. This includes, but is not limited to, ISO 13485 Quality Management Certificates, Authorization Letters from medical device owners, and Circulation Certificates (Certificate of Free Sale) for imported medical devices.
If these documents are not in English or Vietnamese, they must be translated into Vietnamese and certified according to local provisions.

For more information and assistance with navigating these new requirements, please contact our office in VietNam.

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Asia Actual is a leading medical device consultancy in Asia, specializing in medical device registration and regulatory support to help manufacturers increase sales in challenging Asian markets. We offer comprehensive services, including independent license holding, direct fulfillment, and strategic sales channel support, to ensure your medical devices succeed in the region.