Register for Upcoming Webinar on DEC. 8 @ 11AM
2025 China NMPA Bluebook is here:
This webinar covers China post market surveillance (PMS). NMPA (CFDA) has started to put more emphasis on post market supervision than ever before. Three key areas will be discussed: adverse events (AE), recalls and overseas inspection. Two key regulations were issued in the past year on AEs and overseas inspection.
Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation issued on August 31st was implemented January 1st, 2019. For the 1st time, NMPA (CFDA) imposed severe penalties for violations. On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. Provincial NMPA (CFDA) offices will take major responsibility for surveillance whereas overseas inspection responsibility resides at the national NMPA (CFDA) office.
Topics covered:
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