1. A medical device registration certificate is valid for 5 years. According to national regulations, applicants/registrants shall apply for registration renewal no later than 6 months prior to the certificate expiry date. However, the registration renewal shall not be granted under any of the following circumstances:
(1). The applicants/registrant fails to submit the application within the prescribed time limit.
(2). The mandatory standards for medical devices have been revised, and the product fails to meet the new requirements.
(3). For medical devices required for the treatment of rare diseases or urgently needed to respond to public health emergencies, the items specified in the Medical Device Registration Certificate have not been completed within the prescribed time limit.
2. Handling process
(1). The certificate issuing authority is in charge of processing the applications for registration renewal.
(2). The Administrative Service Hall will transfer the application dossiers that pass formal examination to the Center for Medical Device Evaluation.
(3). The Center for Medical Device Evaluation will evaluate the materials within 60 working days for class Ⅱ and 90 working days for class Ⅲ. Devices if supplementary materials are required, a Deficiency Letter will be issued after evaluation. For more information on supplements, see “Supplementary Process”.
(4). The Center for Medical Device Evaluation will make a decision within 20 working days after technical evaluation. The renewal certificate shall be issued within 10 working days since the date of the approval decision.
3. TIPS
Where an original Medical Device Registration Certificate is granted under the condition that the applicants/registrants should complete certain tasks specified in the certificate, a corresponding summary report and accompanying materials shall be provided in the application dossiers.
When applying for renewal, an applicant/registrant shall submit the original certificate, which may be submitted by post.
An applicant/registrant can check the Registration Certificate No. and approval date of the registration. For more information, see “Review and Approval”.
