What is NOT a Medical Device?
Not every health-related product is a medical device. The following categories are generally excluded from the scope of Decree 98/2021/ND-CP:
Medicines and biologicals
Products whose principal intended action is achieved through pharmacological, immunological, or metabolic means are medicines, not medical devices. This includes vaccines, antibiotics, and other pharmaceuticals regulated under the Law on Pharmacy 2016.
Cosmetics
Products intended solely to cleanse, perfume, change appearance, or protect the body — such as skincare creams, shampoos, or lipsticks — are regulated as cosmetics, not medical devices, provided they make no medical claims.
Food and food supplements
Nutritional products, dietary supplements, and functional foods are regulated under food safety law, not medical device law, unless they incorporate a device component with a separate medical intended purpose.
Personal protective equipment (PPE)
General-purpose PPE (e.g. hard hats, industrial gloves) is regulated under labour safety rules. However, some PPE that makes medical claims — such as surgical gloves or medical face masks — is regulated as a medical device.
Borderline cases to watch
| Product type | Key question | Likely outcome |
|---|---|---|
| Wound dressings | Do they claim active therapeutic effect? | Usually device |
| Surgical gloves | Labelled for surgical use? | Medical device |
| Thermometers | Clinical intended use? | Medical device |
| Compression hosiery | Medical claim or purely cosmetic? | Context-dependent |
| Teeth whitening kits | Concentration of active ingredient? | May be cosmetic or device |
| Contact lenses | Corrective vs cosmetic? | Usually medical device |
When a product is used for both a medical and a non-medical purpose, its regulatory status is determined by its primary intended use. If the medical use is primary, it is a medical device.
Getting a determination
If your product falls into a grey area, you can request a formal determination from the Drug Administration of Vietnam (DAV). Provide the intended purpose statement, labelling, and IFU, and DAV will advise which regulatory pathway applies.