Technical Guidance On Clinical Evaluation Of Medical Devices Part 3 Clinical Trial (Draft)


Technical Guidance on Clinical Evaluation of Medical
Part Three: Clinical Trial
I Introduction
(I) Definition of Clinical Trials
A clinical trial is defined as a systematic trial or study conducted in
one or more participants to evaluate the safety, clinical performance, and /
or effectiveness of a medical device.
(II) Purposes of Clinical Trials
Clinical trials are designed to evaluate the safety, clinical
performance and / or effectiveness of a product within its scope of
application or specific intended use.
(III) How to Conduct a Clinical Trial
Good Clinical Practice specifies the requirements for conducting
clinical trials. Clinical trials must consider the scientific principles of
clinical data collection and the accepted ethical standards surrounding the
application of participants.
II Scope
The purpose of this document is to provide the following guidance:
(I) When shall clinical trials of medical devices be conducted to
demonstrate compliance of the product with relevant basic principles
of safety and performance;
(II) General principles for clinical trials of medical devices.
Given the wide diversity of medical devices and their risks, this
document does not provide comprehensive guidance for clinical trials of
specific medical devices.
This document applies to medical devices but does not include vitro
diagnostic devices. This document aims to address issues related to the
use of clinical trials for marketing support and some aspects may apply to
post-market research
III General Considerations for Whether a Clinical Trial
Shall be Conducted
(I) When to conduct a clinical trial
When other data sources (such as literature or non-clinical testing)
cannot demonstrate compliance with the basic principles of safety and
performance (including safety, clinical performance, and acceptability of
benefits / risks), clinical trials are required. When conducting a clinical
trial, the data obtained is applied in the clinical evaluation process of the
product and will be part of the clinical evidence.
When considering whether a clinical trial is needed, it is necessary to
consider whether there are new issues regarding the safety, clinical
performance, and / or effectiveness of a particular device within its scope
of application. Generally, such problems are more common in high-risk
and / or new devices.
Clinical trial data required by new technologies may not be needed
for mature technologies. In the case where no new risks are identified and
the scope of application remains unchanged, for mature technologies,
existing clinical data (such as published literature, clinical experience
reports, post-market reports, adverse event data, etc.) may already fully
confirm its safety, clinical performance and / or effectiveness
(II) Key considerations for whether a clinical trial shall be

  1. Identify the basic principles of safety and performance that need
    to be supported by clinical data (e.g. specific acceptability of safety,
    clinical performance, benefits / risks);
  2. Risk management activities help to identify required clinical data
    to address remaining risks and clinical performance issues that cannot be
    fully addressed by existing information (such as product design,
    preclinical and material / technical evaluation, compliance with relevant
    standards, labeling, etc.).
    Risk control measures include product design, protection measures
    of the product itself or the production process and inherent security
    brought by safety information. The expected benefits of medical devices
    used in clinical diagnosis and treatment must outweigh the residual risks.
    The risks / benefits of the product in specific patient groups may need to
    be further clarified by clinical trials