China’s CFDA (China Food and Drug Administration) wants to boost the country’s innovative device industry. A response to new European legislation on medical devices. Recently the CFDA has released a draft, “Special Review and Approval Process for Innovative Medical Devices,” which makes the review and approval process for innovative devices more efficient.
To define “innovative” as part of the eligibility requirements, “The primary functioning mechanism of the medical device shall be the first of its kind in China, and the device’s efficacy or safety profile shall be fundamentally improved as compared with other similar products.”
Apart from the efforts to improve the efficiency of the review and approval process for medical devices, the CFDA also intends to simplify the application materials required in the license re-registration process for medical devices.
Publication date: 2013-05-03