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 4 technical review guidelines, covering ophthalmology, hematology and microbiology:
- Ophthalmology: technical review guideline on femtosecond laser system
- Ophthalmology: technical review guideline on diagnostic ultrasound system
- Hematology: technical review guideline on continuous glucose monitor
- Microbiology: technical review guideline on cell mediated immune response assay for mycobacterium tuberculosis
CFDA announced recall notices to 22 medical devices from 17 foreign manufactures. Boston Scientific, Siemens, Becton Dickinson, GE, Smith & Nephew are on the list. Read More
- CFDA granted approval for revascularization device, registered by MicroPort Scientific. The device is the first of its kind in China.
- CFDA published directory of registered medical devices for Feb 2018. 20 imported class III and 18 imported class II devices have been approved. Medtronic, Roche, Philips and Stryker Instruments are on the list.
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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.