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Type C & D Devices

Type C and Type D devices are higher-risk devices requiring full Marketing Authorisation (Đăng ký lưu hành) from DAV before they can be placed on the Vietnamese market.

Type C — Medium-to-high risk​

Type C covers devices that are significantly invasive, active therapeutic devices, or pose substantial risk under foreseeable misuse. Examples include:

  • Ventilators and anaesthesia machines
  • Haemodialysis equipment
  • Infusion pumps (active)
  • X-ray equipment and CT scanners
  • Powered surgical instruments
  • Bone screws and orthopaedic implants (non-active)
  • Surgical gloves
  • Intraocular lenses
  • Catheters (long-term use)
  • Blood glucose metres (patient self-testing)

Type C classification criteria (common indicators)​

  • Surgically invasive devices intended for short-term use
  • Active therapeutic devices delivering energy to the patient
  • Active devices intended to administer or remove substances to/from the body
  • Long-term implantable devices (excluding those in Type D anatomical locations)

Type D — Highest risk​

Type D is reserved for the highest-risk devices — those that contact the central circulatory system or central nervous system, or that rely on biological or viral inactivation processes. Examples include:

  • Cardiac pacemakers and implantable defibrillators
  • Heart valves
  • Neurostimulators and deep brain stimulators
  • Vascular grafts (central circulation)
  • Spinal cord stimulators
  • Devices incorporating animal tissues or derivatives
  • Blood bags and blood transfusion sets (with direct contact with blood under pressure)
  • HIV diagnostic IVD kits (Type D for IVD — see IVD Classification)

Type D classification criteria (common indicators)​

  • Implantable devices contacting the central cardiovascular or CNS systems
  • Devices incorporating human/animal tissues or cells
  • Long-term implantable active devices
  • Highest-risk IVD devices (blood bank screening, HIV detection)

Market access route for Type C and D​

Both classes require a full marketing authorisation through DAV. See Marketing Authorisation (Type C/D) for the full procedure, dossier requirements, and review timelines.

Type D — plan for longer review times

Type D devices receive the most intensive DAV scrutiny. Build additional review time into your project plan — initial assessments suggest Type D applications can take significantly longer than Type C.