The Center for Medical Device Evaluation of China (CMDE) issued two announcements in early June. These announcements relate to the medical device registration:
According to the Announcement No 16 of 2020, after receiving the set of documents from the applicant, the authorization body starts to check it in accordance with the file examination requirements. If it requires correction, the applicant has the opportunity to correct the documents within this first submission. When resubmitting, it is necessary to follow the relevant requirements to associate the previous registration with the amendments. Otherwise, it will be considered as a new application and the whole procedure will be started from the very beginning.
These changes in the regulation will help the authority to provide better services and improve the efficiency of the review.
Announcement No 42 of 2020 concerns registration withdrawal and re-application procedures for imported medical devices. Thus, if a class-II medical device was submitted but after the documentation review the authority body has determined that the device actually falls under class III, the CMDE issues the conclusion on non-approval of the device.
When the applicant wants to re-submit the application, it is necessary to attach a copy of the conclusion about non-approval along with an explanation of the circumstances leading to the re-submission procedure.
Links to the official documents:
The information has been prepared by the GMA Consult Group team.
GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.
Need your own guide to the world of certification and approvals? Don't hesitate to contact us via email@example.com.