Weekly CFDA News Roundup covers government reports, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) a consulting firm specializing in China CFDA regulatory, CRO and market access services.
CFDA published “Fourth Batch of Clinical Trial Exempted Medical Devices (Draft)” and “Revised Version: First Three Batches of Clinical Trial Exempted Medical Devices (Draft)” for feedback. 85 medical devices and 277 IVDs have been newly-exempted from clinical trial. In total, 860 class II and 201 class III devices and IVDs have been granted exemption from clinical trial. Feedbacks need to be summited by June 30, 2018.
For complete list of the exemptions, please email info@ChinaMedDevice.com.
CFDA published Industry Standard on Quality Management System of Medical Device (Draft) for feedback. Feedbacks need to be submitted by June 30, 2018.
CFDA issued Clinical Trial Application Dossier Guideline on Implantable Medical Device.
CFDA announced a recall notice from foreign manufacturer:
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, QA, post market compliance. We are certified as legal agent. 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+ companies’ success.