Devices must have patents or patents pending as well as “significant clinical value” in order to qualify for expedited review; foreign manufacturers must still provide all required technical information and documentation for Chinese medical device registration. The CFDA’s Medical Devices Evaluation Review office will determine qualification of applicants into the new program. Qualified medical devices will be prioritized by reviewers and manufacturers will receive “enhanced communication” during the review process.
Although the expedited market pathway will not curtail or forego any steps in the standard medical device registration process in China, it could mean faster review timeframes if effectively implemented by the CFDA. That’s potentially very good news for foreign manufacturers seeking market authorization in China but daunted by the market’s complex regulatory requirements.
REFERENCE: Emergo Group; Stewart Eisenhart; 13 FEB 2014