NMPA Collecting Public Comments On The Drafts Of Terms And Definitions For Medical Device Clinical Evaluation And IVD Clinical Performance Studies

On August 10, 2022, NMPA issued a notice to collect public comments to establish industry standards of MD clinical evaluation and IVD clinical performance studies in terms and definitions.

NMPA released the Medical Device Clinical Evaluation-Terms and Definitions (2022 Draft for comments) and Clinical Performance Studies of In Vitro Diagnostic Reagent – Terms and Definitions (2022 Draft for comments). Both documents define terms and definitions for medical device and IVD clinical evaluation, including those commonly used in clinical investigation designs, conducts, records and reports. It lays the foundation for medical device clinical evaluation. The standard involves no specific products and serves as a recommended one, which will be implemented 12 months after publication.

It is a great opportunity to have your voices heard by NMPA reviewers and get involved in the process. If you have any comments on this, please contact info@bradyknowmedical.com before October 1, 2022. We will help you submit your comments to NMPA before October 8, 2022.