What is a Medical Device?
Under Article 76 of MDSAR 2021, a medical device is defined as any instrument, equipment, appliance, in vitro diagnostic reagent, calibration material, material, or other similar or related article β including required software β that meets all of the following:
- It is used alone or in combination for human beings.
- Its intended purpose is diagnosis, prevention, monitoring, treatment, alleviation, or compensation of a disease or injury; examination, replacement, adjustment, or support of a physiological structure or process; supporting or sustaining life; pregnancy control; or examination of samples taken from the human body.
- Its primary intended action in or on the human body is not achieved by pharmacological, immunological, or metabolic means β though it may be assisted by such means.
This is the foundational definition. If a product meets this definition, it is subject to NMPA regulation regardless of where it is manufactured.
Examples of medical devicesβ
| Product | Class (typical) |
|---|---|
| Blood glucose meter | Class III |
| Disposable syringe | Class II |
| Examination gloves | Class I |
| MRI scanner | Class III |
| Stethoscope | Class I |
| Coronary stent | Class III |
| Contact lenses | Class III |
| Surgical drapes | Class I or II |
Products at the boundaryβ
Several product categories sit at the boundary between medical devices and other regulated products (drugs, cosmetics, health foods). See Borderline and Combination Products for how NMPA resolves these cases.
Next stepβ
Once you have confirmed a product is a medical device, the next question is its classification. See How Classification Works.
- NMPA β www.nmpa.gov.cn
- CMDE β www.cmde.org.cn
- NMPA Medical Device Registration Query β datasearch.nmpa.gov.cn
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.