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Classification Overview

Vietnam uses a four-class risk-based classification system aligned with the ASEAN Medical Device Directive (AMDD). The class a device is assigned determines which regulatory pathway applies for market access.

The four classes​

ClassRisk levelMarket access route
Type ALowest riskSelf-declaration (Công bố) — no pre-market DAV review
Type BLow-to-medium riskDeclaration (Công bố) with technical dossier
Type CMedium-to-high riskMarketing Authorisation (Đăng ký lưu hành)
Type DHighest riskMarketing Authorisation (Đăng ký lưu hành)

How classification is determined​

Classification is based on a set of rules defined in Decree 98/2021/ND-CP and Circular 14/2020/TT-BYT, which mirror the ASEAN harmonised classification rules. The key factors are:

  • Intended purpose — what the device is designed to do
  • Duration of contact — transient (< 60 min), short-term (60 min – 30 days), long-term (>30 days)
  • Degree of invasiveness — non-invasive, invasive, surgically invasive, implantable
  • Whether the device is active — powered or non-powered
  • The body systems or organs affected — some anatomical locations (e.g. central circulatory system, central nervous system) automatically elevate classification

Multiple rules — take the highest class​

If more than one classification rule applies to a device, the highest resulting class applies. For combination devices or accessories, each component or accessory is classified separately.

Who determines the class?​

The manufacturer is responsible for determining the correct classification based on the published rules. However, DAV has the authority to:

  • Request reclassification if it disagrees with the manufacturer's determination
  • Issue formal classification opinions on request
Request a DAV classification opinion

If your device falls into a grey area between two classes, it is worth requesting a formal written opinion from DAV before committing to a full registration dossier. This avoids costly rework if DAV disagrees with your classification.

IVD devices​

In-vitro diagnostic devices follow a separate set of classification rules. See IVD Classification.

ASEAN harmonisation​

Vietnam's classification rules are directly derived from the ASEAN AMDD classification framework, making them broadly compatible with rules applied in Singapore (HSA), Malaysia (MDA), Thailand (FDA Thailand), and other ASEAN member states. See ASEAN & International.