In early June, China Medical Device Evaluation Center (CMDE) issued two announcements related to medical device registration.
– Announcement No 16 of 2020
– Announcement No 42 of 2020
1) According to No 16 of 2020, the certification body will start reviewing the files according to the file review requirements after receiving the relevant documents from the applicant, and if necessary, the applicant can modify the documents within this first submission.
Upon re-submission, the relevant requirements must be followed to associate the previous registration with the amendment, otherwise it is considered a new application and the entire process begins from the beginning.
2) Announcement No 42 of 2020 relates to the procedure for withdrawal and reapplication of imported medical devices.
If a medical device for Class II has been submitted, but after reviewing the institution’s documentation, it is determined that the device actually belongs to Class III.
If the applicant wishes to resubmit the application, a copy of the results of the disapproval must be attached with a description of the circumstances leading to the resubmission.