NMPA Challenges & Pitfalls & Analysis

Adverse events: unfavourable medical events that occur during clinical trials, regardless of whether they are related to experimental medical devices.Serious adverse events： deaths or serious deterioration of health that occur during clinical trials, including fatal diseases or injuries, permanent defects of body structure or body function, need for hospitalization or prolonged hospitalization, and need for medical treatment or surgery Intervention to avoid permanent defects in body structure or body function; events such as fatal distress, fatal death, or congenital abnormalities or congenital disabilities.In China, CTCAE (Common Terminology Criteria for Adverse Events) is usually used for judging AE severity as Grade 1, Grade 2, Grade 3, Grade 4, and Grade 5. All AEs should be recorded in the Original Medical Record and CRF in a timely and accurate manner. SAE should be reported to the GCP office of the clinical study site, IRB, local NMPA, and local Health Commission within 24 hours.Takeaway: SAE report is of a stringent timeframe, which should be done in 24 hours.

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For NMPA approved products in China, an adverse event shall be reported to NMPA if it causes or is likely to cause serious injury or death.Refer to Article 27 of the “Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events” (Order No. 1 of the State Administration for Market Regulation): the agent designated by the foreign certificate holder and the certificate holder of a domestic medical device shall report within 30 days from the date of discovery or awareness.Takeaway: Adverse events for approved in China occur overseas should be reported to NMPA within 30 days since awareness.

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When a medical device is registered and marketed in China, even if the Chinese market is not affected, it still needs to be reported to the NMPA.Refer to Article 6 of the Measures for the Administration of Medical Device Recall: The agent designated by overseas manufacturers of imported medical devices in China shall promptly report the relevant information about implementing medical device recalls abroad to the State Food and Drug Administration.Takeaway: Recall/field action for approved in China that occurs overseas shall report to NMPA.

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If the production date of the medical device is within the validity period of the expired registration certificate, it can be sold. Approved medical devices for registration refer to medical devices consistent with the contents of the medical device registration certificate and accessories and manufactured within the validity period of the medical device registration certificate.Refer to Article 112 of the “Administrative Measures for the Registration and Filing of Medical Devices.”Takeaway: The medical device manufactured within the validity period can be sold.

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If the parts or accessories are medical devices, they must have Chinese labels when they are imported separately.Refer to Article 2 of the Regulations on the Administration of Medical Device Instructions and Labels: All medical devices sold and used within the territory of the People’s Republic of China shall be accompanied by instructions and labels by the requirements of these regulations.Takeaway: Parts and accessories need to have Chinese labels.

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The production date of the product is within the validity period of the registration certificate, and it is regarded as a certified product. Imported products produced outside the valid period of the registration certificate shall be regarded as unlicensed products and cannot be imported.Approved medical devices for registration refer to medical devices consistent with the contents of the medical device registration certificate and accessories and manufactured within the validity period of the medical device registration certificate.Refer to Article 112 of the “Administrative Measures for the Registration and Filing of Medical Devices.”Takeaway:On Sep 2, 2021, NMPA officially mentioned that imported products produced outside the valid period of the registration certificate shall be regarded as unlicensed products and cannot be imported.

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