This session of the webinar introduces medical device regulation milestones in China which is from 2014-2021. Then it talks about the Hierarchy of NMPA Requirements, it divides to regulation, provision, notifications, technical review guidance, and national and industry standard. Finally, it briefly talks about major changes in order 739 which includes new exemptions, new regulatory pathways, new clinical evaluation requirements, MAH Regime, increased administrative penalties for illegal conduct and repositioning of local legal agent.
