New CFDA Technical Review Guideline for CT

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On February 9th, 2018, CFDA issued a new technical review guideline on Computed Tomography X-Ray Systems (CT). CT is categorized as Class III device by CFDA in China.

The guideline covers the following areas:

A. Summary: 1) description of product; 2) model specification; 3) packaging information; 4) intended use and precaution; 5) similar products

B. Research materials: 1) performance; 2) biocompatibility; 3) sterilization; 4) expiration and packaging

C. Manufacturing information: 1) manufacturing process and control; 2) manufacturing site

D. Clinical evaluation

E. Product technical requirements

F. Registration unit

G. Product registration testing report

H. Instruction for use

Over the past year, multiple CT systems from Philips and General Electric were recalled due to issues of patient stent, vertical braking components, etc. The most recent one was from Philips on February 5th, 2018 due to software 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.

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