Although the regulatory process can be challenging due to rapid change, bringing medical devices to market in China is a high-potential future growth area for many global manufacturers.
TORONTO (PRWEB) July 22, 2020
Join experts from Reed Tech, Gary Saner, Sr. Manager, Information Solutions Life Sciences and John Lorenc, Sr. Manager Regulatory Solutions, in a one hour live webinar on Thursday, August 13, 2020 at 11am EDT (4pm BST/UK).
The NMPA is the regulating body in China for drugs and medical devices. Specifically, for medical devices, the NMPA has departments dealing with medical device registration (pre-market approvals) and supervision (post-market requirements). The NMPA has responsibilities including drafting laws and regulations for drugs, medical devices and cosmetics, as well as establishing medical device standards and classification systems. NMPA has implemented an electronic medical device registration management system and has identified UDI requirements. Although the regulatory process can be challenging due to rapid change, bringing medical devices to market in China is a high-potential future growth area for many global manufacturers.
To prepare the world market for regulatory compliance in China, NMPA has published guidance on medical device UDI and require registration and UDI data submission for specific product classes. A UDI pilot began in 2019 and has continued to the present. The first group of products (Group 1, consisting of 64 categories of high-risk implantable devices) are planned for required UDI data submission 2020 October.
This webinar will give an introductory presentation on NMPA current status, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device UDI registration scenarios, China NMPA data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions on the differences between U.S. FDA and China NMPA.
For more information or to register for this event, visit What You Need to Know: Med Device UDI Submission to China.
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