China medical device clinical evaluation terms and definitions are open for industry stakeholders’ comments.
On August 10, 2022, the National Medical Products Administration (NMPA) published a notice seeking public opinions on “Clinical Evaluation/Trial of Medical Devices/In Vitro Diagnostic Reagents: Terms and Definitions”.
The terms and definitions standards were drafted by the Center for Medical Device Evaluation (CMDE) of the NMPA, which lays the foundation for subsequent standards in the field of clinical evaluation of medical devices including In Vitro Diagnostic (IVDs) reagents.
The notice about the China medical device clinical evaluation terms and definitions standard has three parts as follows:
1. Clinical Evaluation of Medical Devices -Terms and Definitions
Scope：This document defines the terms and definitions for clinical evaluation, including those used in the design, conduct, documentation, and reporting of medical device clinical trials. This document is applicable to medical device clinical evaluation.
The document includes a terminology glossary where a total of 54 terms are defined, such as clinical evaluation, clinical data, clinical validation, etc.
2. Clinical Trial of In Vitro Diagnostic Reagents – Terms and Definitions
Scope: This document defines the terms and definitions involved in the clinical trials of in vitro diagnostic reagents, including the terms and definitions used in the design, implementation, recording and reporting of clinical trials of in vitro diagnostic reagents. This document applies to clinical trials of in vitro diagnostic reagents. The document includes a terminology glossary where a total of 49 terms are defined. In this standard, a clear definition of in vitro diagnostic reagents and medical devices is first made, which more clearly distinguishes the concepts of medical devices from in vitro diagnostic reagents.
3. Feedback form to submit comments
The deadline to submit comments on the terms and definitions is October 8, 2022. Please fill in the feedback form and send to the relevant person below by email:
Contact Person: Liu Lu (Medical Devices)
Contact Person: He Jingyun (In Vitro Diagnostic Reagent)
If you would like to know more about medical device clinical evaluations or in vitro diagnostic clinical trials in China, please contact Cisema.