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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