What is Not a Medical Device?
Not every product used in a healthcare setting is a medical device under MDSAR 2021. The following categories are generally excluded:
Excluded product categoriesβ
Drugs and biologics β products whose primary intended action is pharmacological, immunological, or metabolic are regulated as drugs under the Drug Administration Law (DAL 2019), not as medical devices. However, combination drug-device products require a lead-agency determination. See Combination Products.
Cosmetics β products intended solely for external application to improve appearance, skin condition, or body odour, with no diagnostic or therapeutic claim, are regulated under the Cosmetics Supervision and Administration Regulations (2020).
Health foods and dietary supplements β food products making health claims but not therapeutic claims are regulated by the food safety authority (SAMR), not NMPA.
General laboratory equipment β general-purpose analytical instruments (e.g. a standard laboratory centrifuge or pH meter) not labelled for specific in vitro diagnostic use are not medical devices.
Personal protective equipment (PPE) β examination gloves are medical devices, but general-purpose protective gloves (e.g. industrial gloves) are not.
Why the distinction mattersβ
Placing a non-medical-device product on the market as if it were a medical device β or marketing a medical device without registration β are both serious violations under MDSAR 2021 carrying administrative and criminal penalties. See Administrative Penalties.
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