CFDA Oversea Inspection
Following the 13th Five Year Plan from 2016 to 2020, China FDA (CFDA) is planning to conduct oversea inspection covering all imported high risk imported medical devices. Whether you are selling or planning to sell your medical devices in China, you could receive CFDA oversea inspection notice at some point. So far in 2018, CFDA has published its inspection reports for eight foreign medical devices covering U.S. Europe, Japan, and Australia manufacturers. There are more inspection reports and notice coming out. You could be on the NEXT inspection list!
The oversea inspection webinar will include the following contents:
1. Interpretation of the CFDA Medical Device Oversea Inspection Guideline.
2. What are the common observations during the inspection?
2. What are the likely penalties and warnings issued by CFDA?
3. How to prepare for the CFDA oversea inspection?