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January 5, 2024
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
Quick answer
China NMPA IVD registration requires classification of the diagnostic product, local type testing at an NMPA-recognized laboratory, Chinese technical documentation, and clinical evidence or an accepted exemption. Overseas manufacturers also need a China-based legal agent and must obtain the appropriate registration certificate before importation or sale.
NMPA IVD Device Registration in China
Registration and importation of In-Vitro Diagnostic (IVD) devices 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 the application process requires prior home country approval.
Classification and Pathways
IVD devices follow the same three-tiered classification structure as general medical devices, with the pathway determined by risk:
| Class | Risk Level | Pathway | Review Timeline |
|---|---|---|---|
| Class I | Low Risk | Filing/Notification (eRPS) | Approx. 4 weeks |
| Class II | Medium Risk | Registration | 12-24 months |
| Class III | High Risk | Registration | 12-24 months |
Key Local Requirements
-
Legal Agent: Foreign IVD manufacturers must appoint a China-based Legal Agent. This agent is the entity responsible for submitting the registration application, maintaining compliance, and officially controlling the MDRC.
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Local Product Testing: For Class II and Class III IVDs, a mandatory component of the application is the submission of product testing certificates issued by a local NMPA-certified laboratory. Device samples must be provided for this testing phase.
-
Local Clinical Data: A crucial requirement for IVDs is the submission of local clinical test data for all Class II and Class III devices. This data must support the claimed safety and effectiveness of the IVD in the Chinese population. The NMPA provides guidelines and an exemption process for clinical data, but local testing remains a significant hurdle.
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Registered Pharmacist · AI Engineer · Director, ElendiLabs
Registered pharmacist, AI engineer, HKHAIS founder, and pharmaceutical & medical device SEO/GEO specialist.
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