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What is a Medical Device?

Under Decree 98/2021/ND-CP, a medical device is broadly defined as any instrument, apparatus, appliance, software, material, or other article — whether used alone or in combination — intended by the manufacturer to be used on humans for one or more of the following purposes:

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or disability
  • Investigation, replacement, or modification of the anatomy or a physiological process
  • Control of conception

A medical device achieves its principal intended action by means other than pharmacological, immunological, or metabolic action — although it may be assisted by such means.

Key elements of the definition​

Intended purpose matters most. The manufacturer's stated intended purpose — as expressed in labelling, instructions for use, or promotional materials — is the primary factor in determining whether a product is a medical device.

Software can be a medical device. Software that meets the intended-purpose criteria is regulated as a medical device (see Software & SaMD).

Accessories are included. An article specifically intended by its manufacturer to be used together with a device to enable or assist the device in being used in accordance with its intended purpose is considered a medical device accessory and is regulated accordingly.

Combination products and borderline cases​

Some products sit on the boundary between medical devices and medicines, cosmetics, or food. For borderline products, the DAV makes a determination based on the primary mode of action:

  • If the primary action is pharmacological, immunological, or metabolic → it is a medicine (regulated by the Department of Drug Administration)
  • If the primary action is physical or mechanical → it is a medical device (regulated under Decree 98/2021)
When in doubt, ask DAV

If you are unsure whether your product qualifies as a medical device, you can submit a classification or determination request to the Drug Administration of Vietnam (DAV) before investing in a full registration dossier.

IVD devices​

In-vitro diagnostic (IVD) devices — reagents, calibrators, control materials, specimen receptacles, instruments, and software used to examine specimens derived from the human body — are also medical devices and are classified and regulated under Decree 98/2021. See IVD Classification for details.