5:03 Webinar Recording Excerpt
To prepare the world market for regulatory compliance in China, NMPA has published guidance on medical device UDI submission for specific product classes. A UDI pilot began in 2019 and has continued to the present.
Published guidance is available for the first group of products (Group 1, consisting of 64 categories of high-risk implantable devices). UDI data submission is expected to begin January 1st, 2021. For companies looking to future market growth in China, a number of details will need careful monitoring.
This webinar will give an introductory presentation on NMPA current status, what we have learned via testing and a Q&A session.