Do I Need To Report To The China NMPA For Adverse Events That Occur Overseas?

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.