Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.
CFDA issued 5 Technical Review Guidelines as following:
IVD: epidermal growth factor receptor (EGFR) gene mutation assay
IVD: helicobacter pylori antigen/antibody assay
IVD: anti-human globulin assay
IVD: nucleic acid assay for enterovirus RNA
Active: ultrasonic cutting and coagulation system for soft tissue
Others: 3d printed medical device (draft)
CFDA announced Medical Device Recall Notice to Dongyang Songpu for the natural rubber latex condom. The product has been recalled due to water leak test issue.
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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.