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Combination Products & Borderline Devices

Some products combine a medical device with a medicine, biologic, or human tissue, or sit on the boundary between different regulatory categories. These require careful classification before determining the applicable pathway.

Device-medicine combination products​

A product that incorporates both a device component and a medicinal component is regulated based on its primary mode of action:

  • If the device component is primary and the medicine is ancillary → regulated as a medical device under Decree 98/2021
  • If the medicine is primary and the device is ancillary → regulated as a medicine under the Law on Pharmacy

Examples:

  • Drug-eluting stents — the stent is the primary component; the drug coating is ancillary → medical device
  • Pre-filled syringes — the drug is primary; the syringe is ancillary → medicine (but the syringe may require device certification as a component)
  • Antibiotic-impregnated wound dressings — case-by-case determination

Device-biologic combination products​

Products combining a device with cells, tissues, or biological materials are assessed individually. Some biologic-device combinations (e.g. bone grafts incorporating living cells) may require consultation with both DAV and the Department of Science and Technology.

Accessories to medical devices​

An accessory that is specifically intended to be used together with a medical device to enable it to perform its intended purpose is itself regulated as a medical device. The accessory is classified separately from the principal device — it may be the same class or a different class depending on its own risk profile.

Kits and procedure packs​

A kit or procedure pack containing multiple medical devices:

  • Each device component retains its individual classification
  • The kit as a whole is generally classified at the highest class of any of its components
  • If a kit contains a medicine alongside devices, it may require separate regulatory approaches for each component

Second-hand and refurbished devices​

Second-hand, reconditioned, and refurbished medical devices are a specific area of Vietnamese regulatory attention. See Special Device Types for the applicable rules.

Requesting a formal determination​

For any genuinely borderline product, submit a formal written query to DAV before investing in a full dossier. Provide:

  • A clear description of the product and its components
  • The proposed intended purpose
  • Labelling and IFU drafts
  • Any applicable technical standards

DAV will issue a written response indicating the applicable regulatory category and, where applicable, the classification.