CFDA Regulatory Changes 2017
China medical device/IVD regulations
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.