Skip to main content

Type A & B Devices

Type A and Type B devices are lower-risk devices that follow the Declaration (Công bố) pathway rather than full DAV registration.

Type A — Lowest risk​

Type A devices are non-invasive, non-active, or pose minimal risk under normal use. Examples include:

  • Bandages and wound dressings (without active components)
  • Hospital beds and patient hoists
  • Wheelchairs and walking frames
  • Stethoscopes
  • Non-sterile cotton wool and gauze
  • Examination gloves (non-sterile)
  • Corrective spectacles frames (without lenses)
  • Tongue depressors

Type A classification criteria (common indicators)​

  • Non-invasive devices intended to contact intact skin only
  • Devices intended for temporary external use with no active component
  • General surgical instruments (non-implanting, non-active)
  • Devices used by a layperson that pose no direct risk

Type B — Low-to-medium risk​

Type B devices are slightly more complex, may have limited invasiveness or be active, but remain lower risk than Type C/D. Examples include:

  • Examination gloves (sterile)
  • Hypodermic needles and syringes
  • Blood pressure monitors (non-implantable)
  • Thermometers (electronic, clinical use)
  • Suction equipment (non-surgical)
  • Ultrasound gel
  • Basic patient monitoring electrodes (surface)
  • Hearing aids (non-implantable)
  • Dental mirrors and hand instruments

Type B classification criteria (common indicators)​

  • Invasive devices intended for transient use in natural body orifices (but not surgically invasive)
  • Active devices for diagnosis with no direct patient contact energy
  • Non-active devices intended to interact with wounds or mucous membranes

Market access route for Type A and B​

Both classes use the Declaration (Công bố) pathway via the DMEC portal. Type A declarations are largely self-assessed; Type B declarations require a technical dossier. See Declaration (Type A/B) for the full procedure.

Upgrading to Type C/D

If DAV reviews your declaration and concludes the device should be classified as Type C or D, it will require you to withdraw the declaration and submit a full marketing authorisation (Đăng ký lưu hành) application. Any devices already distributed under the Type A/B declaration pathway may be subject to recall or regulatory action.