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January 3, 2024
Approximately 5 minutes
China NMPA Medical Device Registration: Classification, Legal Agent, and Clinical Data
China NMPA Medical Device Registration and Approval
Medical device market entry in China requires a Medical Device Registration Certificate (MDRC) issued by the National Medical Products Administration (NMPA). The MDRC is valid for five years, and renewal applications must be submitted six months prior to expiration. A prerequisite for foreign manufacturers is having home country approval prior to application.
Classification and Regulatory Pathways
The registration pathway depends on the device's risk classification:
| Class | Risk Level | Pathway | NMPA Review Fee (Approx.) | Review Timeline |
|---|---|---|---|---|
| Class I | Low Risk | Filing/Notification | NA | Approx. 4 weeks |
| Class II | Medium Risk | Registration | 210,900 RMB (~$30,000 USD) | 12-24 months |
| Class III | High Risk | Registration | 308,800 RMB (~$44,000 USD) | 12-24 months |
Mandatory Local Requirements
Foreign manufacturers must navigate two critical local requirements:
-
Legal Agent Appointment: A China-based Legal Agent (similar to a Local License Holder) must be appointed. The Legal Agent is responsible for:
- Managing the registration process.
- Providing technical service and maintenance support.
- Assisting with device recalls and adverse event handling.
- Crucially, the Legal Agent controls the MDRC on the foreign manufacturer's behalf.
-
Local Testing and Documentation:
- NMPA-Certified Testing: Product testing certificates must be obtained from a local NMPA-certified laboratory using device samples.
- Language: All information, packaging, and labeling must be translated into Simplified Chinese.
- Home Country Approval: Documentation proving approval in the country of origin (e.g., CE Mark, FDA 510(k)) is required for Class II and III devices.
Clinical Data Requirements
A significant hurdle for Class II and III devices is the requirement for local clinical test data.
- Clinical Trials: Local clinical trials are often required unless the device qualifies for an exemption.
- Clinical Evaluation Report (CER): The NMPA may accept a CER in lieu of a trial if the device qualifies as a "Same Type Device" (predicate device). However, the definition is narrow, making upfront determination difficult. A formal inquiry process exists to seek the performance parameters expected by the NMPA.
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