If The Products That Use CER Or Clinical Trial Pathway For Clinical Evaluation Have Been Listed In The Published Exemption Directory During The Review, Can The Clinical Evaluation Pathway Be Changed When The Applicant Supplements The Dossier?


The technical review of clinical evaluation of medical devices is carried out based on the clinical evaluation dossiers submitted by the manufacturer. If CER or clinical trial pathway is adopted for the clinical evaluation of the medical devices under review, for example, after the applicant submits the registration application dossiers, the declared products are listed in the officially released catalogue of medical devices exempted from clinical trials, and the applicant can complete the clinical evaluation through the catalogue of medical devices exempted from clinical trials according to its needs when supplementing the dossiers. In this case, considering the significant changes in the clinical evaluation dossiers in the supplementary dossiers compared to the initial submission, the applicant can communicate with the reviewers through communication channels including post supplementary consultation and preliminary review.