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.
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The guideline covers the following areas:
- Summary: 1) description of product; 2) model specification; 3) packaging information; 4) intended use and precaution; 5) similar products
- Research materials: 1) performance; 2) biocompatibility; 3) sterilization; 4) expiration and packaging
- Manufacturing information: 1) manufacturing process and control; 2) manufacturing site
- Clinical evaluation
- Product technical requirements
- Registration unit
- Product registration testing report
- 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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For more detailed information or English version of the documents, please contact us at info@ChinaMedDevice.com
About China Med Device, LLC
We provide turn-key solutions for western medical device/IVD companies to enter China with regulatory and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our management team in Boston and Beijing have processed 1,200+ certificates. Email info@ChinaMedDevice.com or visit www.ChinaMedDevice.com
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------