Face to Face Regulatory Affairs with CFDA Representatives from Beijing a Success

Announcement from China Med Device, LLC
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China Med Device Regulatory Affairs event in Boston with CFDA delegates from Beijing’s CFDA gives key Medtech U.S. companies face to face time for questions and preview of “not-yet-published” 2018 updates on policies and requirements for CFDA registration of medical devices/IVD.

China Med Device, LLC, a China market access and regulatory consulting firm with offices in Beijing and Boston, in collaboration with CABA, held a successful face to face meeting with CFDA Representatives from the Center for Medical Device Evaluation (CMDE) in Cambridge, MA on December 10, 2017.

Despite a first big snow and wet roads, nearly 50 regulatory affairs representatives from small and large companies, manufacturers and industry experts attended the interactive dinner event for the rare opportunity to speak with the CFDA delegates directly, hear about forthcoming “not-yet-published” CFDA policies and requirements, and ask questions directly of the CFDA registration experts from China.

Participants came from near and far companies such as Medtronic, Johnson and Johnson, Zimmer Biomet, and Neuroelectrics, etc. Zimmer Biomet’s Satomi Kitabayashi, Regulatory Affairs Project Manager, traveled from Indiana to attend the event and appreciated, “meeting and talking with the CFDA reviewers face to face, and meeting with the regulatory professionals from the different companies.” Attendees gained insights from not only the key note speakers, and the moderator, but also from each other as colleagues.

CEO of China Med Device, Grace Fu Palma, kicked off the meeting with a high-level overview of the medical device and IVD CFDA registration processes and the differences between CFDA and FDA, and the different registration pathways. She highlighted how to be more effective in shortening the registration time line from technical and performance testing, to clinical evaluation and emphasized the importance of direct communication with CFDA reviewers. Then she introduced two special guests from CFDA, Director Bin Liu and Reviewer Yue Min. Mr. Liu and Ms. Min who came from the CFDA’s Center for Medical Device Evaluation (CMDE) in Beijing.

Bin Liu, director of Division IV, Center for Medical Device Evaluation of CFDA, is a biological materials research professor and a member of the State Ministry of Science and Technology’s “Additive Manufacturing and Laser Manufacturing Special Focus Experts Group. Yue Min, is a technical registration reviewer for orthopedic implants and surgical devices at Division IV.

One of Mr Liu’s key initiative is to support Innovation efforts in China in the life sciences 3D printing industry. He has been leading the top scientists and the industry in China to develop new CFDA registration standards and guidelines for China medical device 3D printing. He and Yue Min expect to hold an expert panel in January 2018 and to release the medical device registration on 3D printing guideline in the subsequent few months.

Sandra Maher, M.S., RAC, director Regulatory Affairs at ICON appreciated the face to face time with the delegates, and Grace Fu Palma’s domain knowledge and expertise between US FDA and China CFDA.She said, “Ms. Palma’s deep 20+ year of Sino-US medtech experience has provided the insights and background about why CFDA does certain things and the differences between CFDA and FDA. The understanding helped me to be more effective in working with CFDA registration in the future.”

Questions asked of the CMDE representatives centered around protocol for repeating testing, acceptance of biocompatible reports, type testing in China, the inconsistency of opinions of reviewers, predicate home country approval requirements, and supplier records like FDA device master file.

Sally Maher, a previousVP Clinical & Regulatory Affairs at Edwards Lifesciences VP of Edwards Life Science, now a Clinical and Regulatory Affairs Consultant also, “liked the opportunity for face to face dialogue with the CMDE representatives, have her questions answered, and the dinner event was really appreciated as it gave us an opportunity to network as well.”

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.

China Med Device, LLC, specializing in providing turn-key solutions for medtech companies’ entry into China, brings you up-to-date information on medical device registration, regulation and policy updates. If you have any feedback or have an inquiry, please email us at info@ChinaMedDevice.com or visit us at www.ChinaMedDevice.com.

About China Med Device, LLC

China Med Device, LLC, provides turn-key solution for medtech/IVD companies to enter China in regulatory and commercialization.

Press Contact

Viki Chen

Interview Availability

Grace Fu Palma, CEO of China Med Device, will be available from December 27th, 2017 to January 4th, 2018. Contact Viki Chen for scheduling.