NMPA Notice On Adjustment Of Technical Consultation About Medical Devices Registration Before Application Acceptance

In order to comprehensively promote the development of China’s medical device industry and give full play to the technical support role of the medical device innovation service station for the development of medical device industry in the region, NMPA issued Notice on Adjustment of Technical Consultation about Medical Devices Registration before Application Acceptance (NMPA, No. 37, 2022) on October 16, 2022.

CMDE as the lead unit, responsible for the overall management and organization of the implementation of technical issues consulting work before registration acceptance. Drawing on the experience of the Yangtze River Delta Sub-Center for Devices and the Great Bay Sub-Center for Devices to carry out pre-registration technical issues consultation work, medical device innovation service stations in Sichuan Province, Jilin Province and Fujian Province, Beijing Municipal Medical Products Administration and Hainan Medical Products Administration are as a participating unit into the scope of pre-registration acceptance of technical issues consulting work.

The notice mainly describes the technical issues consultation before the acceptance of medical device registration, including on-site consultation time, on-site consultation location, consultation object and scope, consultation arrangements, consultation form, notes and contact information.

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