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September 16, 2025
Approximately 5 minutes
Medical Device License: Amendments for Post-Approval Changes
Vietnam Medical Device License Maintenance: Mandatory Amendments for Post-Approval Changes
License maintenance is a critical and often unique consideration for medical device manufacturers in Vietnam. Unlike jurisdictions like the U.S. or Europe, where certain changes can be documented retrospectively, Vietnam typically requires formal regulatory action before a modified device can be imported or sold. This is governed by the principles laid out in Decree 98/2021.
The Requirement for Mandatory Amendments
In Vietnam, changes made to a registered medical device or its production process generally require an amendment to the existing Market Authorization (MA) License. This proactive approach is mandatory to ensure customs clearance and maintain market access.
Failure to obtain the required amendment before importing the updated device can result in customs clearance delays or potentially the suspension of market activities.
Changes Requiring a License Amendment
Manufacturers must notify the Ministry of Health (MoH) and submit an application for amendment for the following types of changes:
- Administrative Changes:
- Change to the address of the product owner or the local License Holder.
- Change to the name of the License Holder.
- Change to either the name or the address of the product manufacturer (a change to both may require a new registration).
- Product/Packaging Changes:
- Changes to the product packaging (specifically for IVDs).
- Changes to the labels and Instructions for Use (IFU), provided that the product's fundamental indication or intended purpose remains unchanged.
- Other Changes:
- Changes to the warranty establishments.
The Amendment Process
The notification of the change should include:
- A formal notification letter detailing the modifications.
- All relevant supporting documents related to the change (e.g., revised certificates, updated labels, etc.).
The local License Holder plays an indispensable role in managing this process, as they are the legally responsible entity for filing the amendment application and ensuring compliance with the updated documentation before the new product version enters the country.
Important Notice: The interpretation of what constitutes a 'permissible' modification versus a 'significant' change that requires a completely new registration can vary. Manufacturers should always consult with their local regulatory professional to determine the correct pathway to maintain continuous compliance.
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