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QMS Overview

A functional quality management system (QMS) is a prerequisite for medical device market access in Vietnam and for ongoing compliance with Decree 98/2021/ND-CP.

What QMS standard applies?​

Vietnam aligns with ISO 13485:2016 — the international standard for quality management systems specific to medical devices — as the recognised QMS standard for manufacturers and, to a degree, for importers and distributors.

Under Decree 98/2021:

  • Manufacturers submitting Type B declarations must provide evidence of a QMS (ISO 13485 certificate or equivalent)
  • Manufacturers submitting Type C/D registration dossiers must provide a valid ISO 13485 certificate or equivalent GMP certification
  • Distributors and importers are expected to maintain documented quality procedures appropriate to their role in the supply chain

Good Manufacturing Practice (GMP)​

Vietnam's Decree 98/2021 introduces GMP requirements for medical device manufacturers. For foreign manufacturers, GMP compliance is evidenced by:

  • ISO 13485 certification from an accredited certification body
  • MDSAP (Medical Device Single Audit Program) certificate — recognised by DAV as equivalent evidence of GMP compliance
  • National GMP certificate from the country of manufacture's regulatory authority (accepted where bilateral recognition applies)

Vietnamese domestic manufacturers may be subject to direct GMP inspection by MOH/DAV inspection teams.

MDSAP recognition​

The Medical Device Single Audit Program (MDSAP) is a globally recognised audit program covering quality management system requirements for regulatory authorities including Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA), and the USA (FDA).

DAV recognises MDSAP certificates as equivalent to ISO 13485 for the purposes of registration dossiers (Type C and D). This is particularly valuable for manufacturers already MDSAP-certified for other regulated markets (such as the USA, Canada, Japan, Brazil, or Australia), as it eliminates the need for a separate ISO 13485 audit.

QMS and the registration dossier​

The QMS certificate must be:

  • Issued by an accredited certification body (ISO/IEC 17021 accredited)
  • Valid at the time of submission and at the time of registration
  • Covering the scope relevant to the device being registered (correct product category and manufacturing activities)
  • Legalised or apostilled if issued outside Vietnam (confirm current requirements with your Authorised Representative)

An expired QMS certificate is a common reason for registration dossier rejection. Track certificate expiry dates and renew proactively.

Importers and distributors​

While Decree 98/2021 does not mandate ISO 13485 certification for importers and distributors, it does require them to implement documented quality procedures covering:

  • GDP compliance (storage and distribution)
  • Complaint handling and adverse event forwarding
  • FSCA and recall coordination
  • Record-keeping for traceability

These are inspectable obligations — provincial health departments and DAV can request to review quality records during market surveillance inspections.

QMS certificates must be renewed before expiration. If a manufacturer's QMS certificate expires during the validity period of a marketed device's registration, the manufacturer must submit a new valid QMS certificate to DAV within 30 days of renewal. Failure to maintain a valid QMS certificate may result in suspension of the device's marketing authorisation.

Contact your Authorised Representative or DAV's registration department to confirm current document legalisation requirements, as these may vary by country of origin and certification body. Allow additional time in your registration timeline for document preparation and authentication.