Regulatory Affairs Event with CFDA Delegates a Success!

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Regulatory Affairs Event with CFDA Delegates a Success!

Regulatory Affairs consultants and staff had the opportunity to communicate directly with CFDA experts from China's CMDE on Dec. 10, 2017

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.

grace fu palma china med device explains cfda class ii registration timeline

Grace Fu Palma details the Class II CFDA Submission & Registration Timeline for Medical Devices in China at the recent Regulatory Affairs event with delegates CFDA, Director Bin Liu and Reviewer Yue Min in from Beijing’s Center for Medical Device Evaluation.

grace fu palma details the differences between ud fda and cfda

Concrete and critical differences between the U.S. FDA and the CFDA were one of many important discussions at the Face-to-Face Regulatory Affairs event on Dec. 10 with CFDA delegates in attendance to speak directly with Medtech Innovators, Consultants, and Manufacturers.

 

CFDA Yue Min, is a technical registration reviewer for orthopedic implants and surgical devices at Division IV.

Regulatory Affairs representatives from large and small companies had time to network with each other and the CFDA experts at the China Med Device/CABA Regulatory Affairs event on Dec. 10.

CFDA Director Bin Liu visits with regulatory affairs attendee

 

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. More details about the event can be found here. Please contact China Med Device at info@chinameddevice.com or call our office. We welcome your inquiries and questions.