Supplementary Data Pre-review Service
Supplementary data pre-review service, is a consultation service provided by CMDE, whose application scope extends to initial registration, changes in licensing and approval of clinical trials of high-risk medical devices. Given the applicants only have one chance to submit the supplementary data, their registration application can be rejected if the reviewers consider that the submitted supplementary data still cannot prove the safety and efficacy of the product. In addition, the application fee will not be returned even if the application is rejected. Therefore, this supplementary data pre-review service may save the applicants a lot of money. If you need more details about this service, please email info@chinameddevice.cn
