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Ministry of Health · structured requirements

🇻🇳 Vietnam medical device regulatory data

Explore the medical device requirements currently available for Vietnam, organized by topic and linked to official sources.

4 facts3 dimensions3 official sourceslatest verification 2026-08-13

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Authorization duration

authorization.duration
Official document
Type

Indefinite With Ongoing Compliance

Description

Medical-device circulation numbers issued under the current framework are indefinite.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Change-control outcomes

change.available-outcomes
Official document
Outcomes
  • Notification Or Administrative Update
  • New Registration Or New Application
Description

Address and other administrative changes may be notified within a defined period; change result differs by field.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

New-application triggers

change.new-application-triggers
Official document
  • Class A owner/product owner/manufacturer/country changes listed as requiring a new declaration

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Representative or holder change

market-entry.representative-change
Official document
Path Code

Field Specific New Declaration Or Notification

Fresh Registration

Route Dependent

Minimum Handover
  • manufacturer authorization
  • CFS and warranty documents
  • circulation dossier
  • complaints/vigilance/recalls
  • Vietnamese labels
  • import/distribution records
Notes

A holder/manufacturer/country change may require a new declaration; address changes may be notification only.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

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