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CFDA Overseas Inspection: 37 Violations from 8 Foreign Device Manufacturers


CFDA overseas inspection has intensified. On Feb 27, 2018, CFDA announced overseas inspection results from 8 foreign medical device manufacturers with 37 observations. If you need details of these observations, please email

•          Synthes GmbH in Swistzerland: locking plate and stent

•          NovaBone in US: polymethylmethacrylate (PMMA) bone cement and artificial disc

•          3M Health Care in US: securement dressing

•          William A. Cook in Australia: endovascular stent graft and semen cryopreservation fluid

•          Covidien in US: endoscopic linear cutting stapler and single use loading unit

•          St. Jude Medical in US: implantable pacemaker

•          Shimadzu in Japan: digital X-ray Imaging System

•          Terumo in Japan: intravascular catheter

The manufacturers have 50 working days to submit their corrective action plan with evidence of improvement and prevention to CFDA in both English and Chinese. If they cannot meet the deadline, they need to tell CFDA when they will be able to complete the corrective action plan and justify for it.


It is very important for foreign manufactures to be prepared and know what to expect from the CFDA overseas inspection trips.  CFDA issued Guideline for Medical Device Overseas Inspection on Dec 28, 2017. Make sure you read this brand-new guideline especially if you have class III sterile and implantable devices. These are the key target areas. We can help you to interpret and understand the inspection guidelines and prepare you for the on-site inspections.  


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.


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