New 3D printed medical device draft guideline will propel China to be the leader in innovation & market acceptance in orthopedic and dental applications.
CFDA issued “customize-designed additive manufactured (3D-printed) medical device technical review draft guideline” on Feb 26 for feedback. Feedbacks need to be submitted by Mar 30. In this draft guideline, when there is no predicate device to compare to (innovative products) with limited patient volume and no readily available referenced devices, CFDA is only asking for 10 to 20 pairs of observatory study. It can be used in conjunction with history data to do the general analysis. A 3-month follow up period is the minimum requirement to determine the observatory clinical benefits. It is relying on post market follow up evidence with such a short endpoint and small sample size. The detailed outline can certainly help manufacturers in the space to generate the clinical data with different clinical indications a lot faster at much lower cost. With orthopedic sector growing at 20% or so annually, this guideline can certainly propel China to be the leader in orthopedic and dental 3D printed devices.
For a bilingual PPT on the background and principles of this guideline authored by the CFDA committee member, please email gpalma@ChinaMedDevice.com. For the outline of the draft guidance, please click HERE. China Med Device, LLC can help you understand 3D printed devices and get you ready for China market.
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.