Chinese Regulators Publish Timelines for Medical Device Supplementary Information and 2022 Medical Device Standards

Chinese regulators have published the timelines for submitting additional information when a medical device supplementary information notice is issued. Medical device regulators in China have also published the Medical Device Standards Management Annual Report (2022).

CMDE notifies timelines for medical device supplementary information

China’s Center for Medical Device Evaluation (CMDE) has published timelines for submitting additional information when a medical device supplementary information notice is issued.

The timelines are as follows:

• For notices issued before February 20, 2023, the deadline for submission is extended to one year.
• For notices issued beginning from February 20, 2023, the deadline for submission is reinstated to one year.

NMPA publishes 2022 China Medical Device Standards Management Annual Report

The National Medical Products Administration (NMPA) has released the China Medical Device Standards Management Annual Report (2022), which details progress of their activities related to medical device standards in the previous year. According to this report, 40 National Standards (8 mandatory), 114 Industry Standards (9 mandatory), and 4 amendments to Industry Standards for medical devices were released, bringing the number of medical device standards to a total of 1,919 as of December 31, 2022.