China Medical Device Regulatory Changes - Webinar CD/Transcript
China Medical Device Regulatory Changes
If you’re doing business in China or want to — you need to know the latest device regulatory requirements for manufacturing devices there.
Grace Fu Palma — founder of China Med Device — knows them. She has over 20 years of medical device industry experience in China and the United States, working with multi-national corporations and start-ups. Originally from Beijing, she capitalizes on a cross-cultural mindset gained from her experiences in both China and the U.S.
During this session Grace will discuss recent developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. These developments can affect all medical device companies, whether your manufacturing facilities are in China or abroad.
After this 90-minute session you will have a practical understanding of the following compliance issues:
- Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with investigators, resolving issues, and potential penalties.
- Transfer of manufacturing sites and amendment of manufacturing and device licenses.
- Policies and rules on contract manufacturing for medical devices.
- Handling self-inspections and evaluations of past compliance, including recent examples.
Order today and be up-to-date on China’s medical device regulations.