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China’s medical device market sector is growing fast and maintaining double-digit growth for over a decade.A Manufacturer who markets their medical device in China is required to follow China Food and Drug Administration (CFDA) regulations.There are primary Chinese legislation governing medical devices (State Order No.650) released and implemented in June 2014. There are supplemental rules and guidelines that have additionally been released to support this regulation.
The CFDA organized the revision of the provision for the recall of medical devices(CFDA Order No.29) with effective as of May 1, 2017.The provision explained the definition of defective medical device.These defective medical devices shall be recalled.
This whitepaper describes the China FDA Product technical requirements documents(TRD) and approaches that complies to the regulations. HCL Technologies understands the new regulatory requirements and has developed its own execution process and checklists to do the gap assessment, remediation's and implementations. These process approach and checklists listed are a guide to understand the regulations , requirements and helps the medical devices industries across worldwide to manufacture , prepare requirement Technical file or registration dossier for registration and distribution of of the Medical Devices in China FDA.