Regulatory Open Forum

China's Center for Medical Device Evaluation (CMDE) has expanded the number of medium and high-risk medical devices exempt from clinical requirements. The new list includes 142 more medical devices than were previously exempted. Manufacturers of Class II and Class III medical devices can seek an exemption if they can prove to authorities that a product has been on the market for years in another country, that it has been proven safe and effective, that its design is standardized and its use has not changed. Applicants may also be required to submit foreign clinical trial data, including clinical trial protocols.

A complete list of exemption lists and mandates is contained in the CMDE's Classification Catalogue (https://www.cmde.org.cn/CL004/19523.html).

China's Center for Medical Device Evaluation (CMDE) has expanded the number of medium and high-risk medical devices exempt from clinical requirements. The new list includes 142 more medical devices than were previously exempted. Manufacturers of Class II and Class III medical devices can seek an exemption if they can prove to authorities that a product has been on the market for years in another country, that it has been proven safe and effective, that its design is standardized and its use has not changed. Applicants may also be required to submit foreign clinical trial data, including clinical trial protocols.

A complete list of exemption lists and mandates is contained in the CMDE's Classification Catalogue (https://www.cmde.org.cn/CL004/19523.html).