Part 1 Introduction the Webinar——Keep up with the Enhancement of Medical Device Post-Market Surveillance in China: GMP, GSP, and NMPA onsite inspections

Introduction to the regulations

The speaker introduces the development of of medical device regulations in China which are from Order 650(2014) to Order 739(2021). The speaker also used a Medical device regulatory system framework to explained more regulations on Order 739. It talks about some key articles and medical device production quality management standard on-site inspection guidelines in this section.

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UK-China Medical Device Access to China Webinar: Session 1-Navigating Medical Device Lifecycle and Compliance in China
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Previous: Part 7 Stricter Post-market Surveillance Requirements and MAH’s Responsibilities Under Order 739

Next: Part 2 Measures for supervision and adminstration of medical device production (China GMP) and key aspects of onsite inspections.

Part 1 Introduction The Webinar——Keep Up With The Enhancement Of Medical Device Post-Market Surveillance In China: GMP, GSP, And NMPA Onsite Inspections

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