Technical Guidance On Clinical Evaluation Of Medical Devices Part 1 Key Definitions And Concepts (Draft)


Technical Guidance on Clinical Evaluation of Medical
Part One: Key Definitions and Concepts
I Introduction
“Basic principles for the safety and performance of medical devices”
sets out requirements related to the safety and performance of medical
devices, and some provisions specifically point out that when applied in
accordance with requirements, medical devices can achieve their
expected performance. Compared to their expected benefits, the known
and foreseeable risks and side effects have been minimized and are
acceptable. Due to the diversity of medical devices and their technologies, registration applicants and regulators face great challenges in judging
whether the existing evidence is sufficient to prove that the products
comply with the basic principles of safety and performance. Some
technologies have been used for many years so their safety, clinical
performance and / or effectiveness have been fully recognized. On the
other hand, some new technologies are used in products that have not yet
been applied to patients. In addition, due to the wide range and diverse
use experience of ultimate consumers, the clinical application results of
the products may change. Considering the complexity of the application of medical devices, a
case analysis is required to assess whether the clinical evidence is
acceptable when proving the compliance of the products with the basic
principles of safety and performance. Therefore, it is very important to
understand how medical products complete pre-market evaluations and
the role that clinical data and clinical evaluation play in this process. This guidance is intended to provide technical guidance for
registration applicants and regulatory agencies in conducting clinical
evaluations and reviewing clinical evaluation data. It does not involve
administrative matters such as registration approval, nor is it enforced as
a regulation. It should be used in compliance with relevant laws and
regulations. II Scope of Application
The basic concepts of clinical evaluation and clinical evidence are
introduced, and the relationship between clinical trials, clinical data, clinical evaluation and clinical evidence is described. The definitions and
concepts set out in this guidance are aimed at establishing and
maintaining compliance with the