Quality Assurance

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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