CFDA announces: Principle of technical review of medical device software
The CFDA has announced the release of its “Principle of technical review of medical device software” (2015 Order No. 50). This Principle applies to both stand-alone software and software components that are either developed by medical device manufacturers or their design and development partners, including any Off-The Shelf (OTS) software as part of the stand-alone […]
China FDA finalized the rules for priority on review program for some medical devices
The China FDA’s final rule on its priority review program for medical devices will come into force in January 2017. The CFDA’s final guidelineof the rule is open to Class III medical devices manufactured in China and Class II and III devices imported from foreign manufacturers. Chinese market registrants must apply for priority review qualification […]
CFDA issues new document submission rules for Class II and Class III devices
The CFDA has issued new requirements for Chinese market authorization applicants who need to submit hard and soft copies of their registration applications to CFDA. According to the CFDA announcement, Chinese market applicants with Class II and III devices will have to submit not only their original registration dossiers, but also photocopies and soft copies in […]
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