The Korean FDA has been revamping its medical device regulatory system and has implemented many significant changes. In 2012, there are new regulations for pre-market approval, classification, GMP certification, exemptions of KFDA review, etc.
Pacific Bridge Medical invites MassDevice.com readers to learn more about these latest changes in our “NEW 2012 Korean Medical Device Regulatory Changes” webcast on May 3rd.
Case studies will be used to emphasize key points. What you will learn:
- New required licenses
- Key changes on pre-market program
- New KFDA GMP requirements for foreign device companies
- Situations where new local Korean clinical trials are now required
- New device classification