China Med Device and CABA held a quarterly Regulatory Affairs event with CFDA representatives from Beijing in Cambridge, MA on Sunday, December 10.
Nearly 50 Regulatory representatives from U.S. Medtech companies, manufacturers, and industry consultants took advantage of the opportunity to meet and query two special guests from the CFDA; Director Bin Liu and Reviewer Yue Min from the Center for Medical Device Evaluation (CMDE).
Regulatory Affairs representatives from small and large companies, manufacturers and industry experts networked with each other and had a rare opportunity to speak with the CFDA delegates directly, hear about forthcoming “not-yet-published” CFDA policies and requirements (coming in 2018), and ask questions directly of the CFDA Director and Reviewer from China.
CEO and Founder of China Med Device, Grace Fu Palma organized and moderated the program that included a high-level overview of the China Medical Device market, growth rates, and opportunities for U.S. companies.
Key takeaways included:
- Forthcoming CFDA premarket approval changes and updates will impact medical devices premarket approval, clinical evaluation and clinical trials.
- How to avoid common pitfalls in CFDA premarket submission process (technical, clinical and documents) is possible.
- How CFDA 3D printing medical device registration guidelines are more concrete and actionable than the U.S. FDA guidelines which happened to be released a few days before the CFDA delegates visit.
For those unable to attend the event, a copy of the presentation is available by request. Please contact China Med Device at email@example.com or call our office. We welcome your inquiries and questions.