YY/T 1930-2024Medical device clinical evaluation - Terms and definitions (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part

1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The institution does not bear responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Medical Device Clinical Evaluation Standardization Technical Authority. This document was drafted by: Medical Device Technical Review Center of the State Food and Drug Administration. The main drafters of this document. Liu Yinghui, Liu Lu, Cheng Weilu and Cui Xinyue. Medical Device Clinical Evaluation Terms and Definitions

1 Scope

YY/T 1930 fixes the vocabulary of medical device clinical evaluation in China. It specifies the terms and definitions related to the clinical evaluation of medical devices, including those used in the design, conduct, recording and reporting of device clinical trials. Clinical evaluation, equivalence, clinical data and clinical evidence are words that carry different weight in different regulatory systems, and a Chinese submission that borrows a European or American usage can be read as claiming something it did not intend. This document is the terminology base under YY/T 0297, the general quality requirements for device clinical investigation. For a manufacturer preparing a clinical evaluation report for China, or adapting one written for another market, this is the document that settles what each term means to the reviewer.

This document defines the terms and definitions involved in the clinical evaluation of medical devices, including the design, implementation, recording and reporting of clinical trials of medical devices. terms and definitions used in reporting, etc. This document applies to the clinical evaluation of medical devices. This document does not apply to in vitro diagnostic reagents.

2 Normative references

This document has no normative references.