China Medical Device Regulations
Regulatory Agency
The National Medical Products Administration (NMPA) regulates medical devices in China.
Medical Device Definition
Medical device: means any instrument, apparatus, appliance, material, or another article, whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by utilizing pharmacology, immunology, or metabolism. Still, it may be assisted in its function by such means, the use of which is to achieve the following intended objectives:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions
- Investigation, replacement or modification for anatomy or a physiological process
- Control of conception.
Active Medical Devices: any energy that relies on electricity or other energy, not directly from the human body or gravity. Medical devices that use the energy generated by life to perform their functions.
Medical Device Classification System
| International Classification | Risk Level | Examples |
|---|---|---|
| Class I | Low risk | Bandages, examination gloves, and surgical gowns. |
| Class II | Medium risk | Diagnostic reagents, powered wheelchairs, and artificial joints. |
| Class III | High Risk | Implantable pacemakers, artificial heart valves, and certain diagnostic imaging equipment. |
Regulatory Approval Process
Classification |
Approval procedure |
|---|---|
Class I |
Class I medical devices shall be inspected, approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts. |
Class II |
Class II medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government. |
Class III |
Class III medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council.. |
Additional Information
Approval timeline |
1 month to 36 months (Depends on Class of medical device) |
License validity period |
5 years |
Fees |
Class II :- $29,105 Class III :- $42,616 |
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