Change Notification

After a device has been declared or registered in Vietnam, any changes to the device must be assessed to determine whether a regulatory update is required. Not all changes require DAV notification, but significant changes must be reported — and some require a new application.

Change assessment — the key question

The first step is to assess whether a change is significant or minor:

• Significant change: A change that could affect the safety, performance, or intended purpose of the device → requires regulatory action
• Minor change: An administrative or cosmetic change with no impact on safety or performance → typically no regulatory action required, but records should be updated

Significant changes — what triggers notification or re-registration?

Changes that are generally considered significant include:

Change type	Likely outcome
Change to intended purpose or indications	New registration/declaration required
Design or material change affecting safety/performance	Change notification or new registration
Change to manufacturing site (facility)	Change notification
Change to sterilisation method	Change notification
Changes to labelling affecting safety information	Change notification
New clinical evidence changes benefit-risk conclusion	Change notification
Change of Authorised Representative	Change notification (administrative)

The change notification procedure

For significant changes that do not require a new registration:

1. Assess the change using your quality management change control procedure
2. Document the change rationale and impact assessment
3. Log into the DMEC portal
4. Navigate to the relevant declaration or registration record
5. Submit a change notification with supporting documentation
6. Await DAV acknowledgement (for simple changes) or approval (for changes requiring review)

When a new registration is required

If a change is so significant that it effectively creates a different device — particularly changes to intended purpose or changes that elevate the device's risk class — a new declaration or marketing authorisation application must be submitted.

Minor changes — documentation only

Minor changes (e.g. reformatting of the IFU without content change, minor administrative updates) should be documented in the manufacturer's change control record but do not require submission to DAV. Ensure records are available for inspection.

Maintain a change log

Keep a comprehensive change log for all device changes, whether significant or minor. DAV inspectors may ask to review change history during compliance inspections, and a well-maintained log demonstrates regulatory diligence.