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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. This is particularly valuable for manufacturers already MDSAP-certified for other markets, as it avoids the cost of a separate ISO 13485 certification.

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.