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AdvaMed Webinar: China Adverse Event and PMS
June 12 @ 1:00 pm - 2:00 pm
The session will cover 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. We will cover key requirements of the regulations, discuss its implications on foreign companies, and how foreign companies can take a more proactive role to comply under the new PMS environment in China. Best practice example on overseas inspection will be shared.
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 to be covered include:
- What are the current status of AE and recalls?
- What are the requirements and penalties for AE reporting?
- What should foreign companies do to comply with China new PMS requirements?
- What is the best practice for overseas inspection from preparation to on-site inspection to post inspection follow up?
- What are the requirements for NMPA (CFDA) recalls?
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