Industry forum for additive manufactured (3D-printed) medical device was held by CFDA on 12 March. 70 experts, physicians, manufacturers and CFDA reviewers attended the forum to discuss the details of 3D Printed Medical Device Technical Review Guideline.
Attendees focused on the safety, effectiveness and biocompatibility of Additive Manufacturing (AM) and Interaction Design (IxD). Software issues, raw material powder issues, printer management and access requirements for 3D printed device were also discussed. Some manufactures proposed inclusion of some 3D printed devices, with specific intended use and less risks, as class II devices. Committee members of CFDA concluded that the guideline is to be more comprehensive and specific to regulate the industry and facilitate manufacturers’ registration.
CFDA issued the guideline on Feb 26 for feedback. Feedbacks need to be submitted by Mar 30.
In December 2017, a quarterly Regulatory Affairs event was held by China Med Device and Chinese-American BioMedical Association (CABA) in Cambridge, MA. CFDA Director Bin Liu gave a lecture on technical and registration issues of 3D printed devices.
For English copy of the draft guideline, please email gpalma@ChinaMedDevice.com. Please also email your feedback to us, we will consolidate and send to Director Liu.
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.