Technical Guidance On Clinical Evaluation Of Medical Devices Part 2 Clinical Evaluation (Draft)


Technical Guidance on Clinical Evaluation of Medical
Part Two: Clinical Evaluation
I Introduction
(I) Definition of Clinical Evaluation
The clinical evaluation in this guidance refers to the activities using
scientific and reasonable methods to evaluate and analyze clinical data to
confirm the safety, clinical performance and / or effectiveness are in the
scope of the application of the medical devices.
(II) Entire Life-span Clinical Evaluation
Clinical evaluation should be carried out continuously throughout
the entire life-span of medical devices. In the design and development
phase, clinical evaluation should determine the clinical data required for
pre-market product evaluation and whether clinical trials are needed and
the clinical outcomes to be observed. When the product is on the market,
the product needs periodic clinical evaluation as the product safety,
clinical performance and/or effectiveness information is constantly
updated. The above updated information will be entered into the risk
management process and may cause changes in risk assessments, clinical
trial documents, operating instructions, and post-market activities.
(III) The Importance of Clinical Evaluation
At the time of product registration, the registration applicant should
use appropriate conformity assessment procedures to demonstrate that the
product complies with the Essential Principles of Safety and Performance
of Medical Devices. The registration applicant needs to prove that the
product has achieved the expected performance under the applicable
scope; compared with the benefit, the known and foreseeable risks have
been minimized and are acceptable. Any claims regarding the safety,
clinical performance and / or effectiveness of the medical device may be
supported by appropriate evidence.
Registration applicant need to implement and maintain a post-market
surveillance program for routinely monitoring the product safety, clinical
performance, and / or effectiveness as part of a quality management
system. The scope and nature of post-market surveillance should be
compatible with the product and its applicable scope. The registration
applicant needs to use the data generated by the surveillance program
(such as adverse event reports, post-market clinical trials, clinical
literature data, etc.) to conduct clinical evaluations, product performance
and safety periodically review and risk-benefit assessments, and update
clinical evidence.
Ongoing clinical evaluation allows the registration applicant to
report significant changes in product risk and benefit, or changes in
contraindications, warnings, precautions or instructions, as required by
regulations to regulatory agencies.
(IV) The Process of Clinical Evaluation

  1. Identify basic principles of safety and effectiveness that require
    clinical data;
  2. Identify available clinical data related to the device and its
    applicable scope;
  3. Evaluate the applicability and contribution of clinical data
    according to the need to demonstrate the safety, clinical
    performance and / or effectiveness of the product under its
    applicable scope;
  4. Based on the above process, new clinical data is generated based
    on the need to resolve remaining issues of safety, clinical
    performance and / or effectiveness;
  5. Aggregate all clinical data and draw conclusions about product
    safety, clinical performance and / or effectiveness.
    The results of the above processes should be documented and filed
    in the clinical evaluation report. The clinical evaluation report and the
    underlying clinical data will be used as clinical evidence to support the
    device on the market.
    The registration applicant uses clinical evidence, as well as other
    design verification and confirmation documents, device descriptions,
    labels, risk analysis, and production information, to demonstrate the
    product comply with the basic principles of safety and effectiveness. The
    above information and documents are part of the medical device technical
    (V) Detailed Grade of Clinical Evaluation
    The clinical evaluations should be thorough and objective (including
    both favorable and unfavorable data) for effectively proving the product
    safety, clinical performance and / or effectiveness. However, the types,
    history, and risks of technologies applied in products vary widely. Many
    products are developed or improved through incremental innovation and
    are not completely new. Such products can often use clinical experience
    and literature reports that compare device safety, clinical performance,
    and / or effectiveness as their clinical evidence, thereby reducing the need
    for declared products conducting clinical trials to collect data. Similarly,
    if the product is based on technology whose safety, clinical performance,
    and / or effectiveness have been fully validated, it can meet the
    requirements for clinical evidence by meeting accepted acceptance
    The depth and breadth of the clinical evaluation need to comply with
    the nature, applicable scope, and risks of the product. Therefore, this
    guidance will not address specific requirements for clinical evaluation.
    II Scope
    This document is intended to guide registration applicants on how to
    conduct and document clinical evaluations before and after the product is
    on the market and take it as part of the compliance assessment process. At
    the same time, this document is intended to guide regulatory agencies on
    how to evaluate clinical evidence submitted by registration applicants.
    This document includes: 1. Basic principles of clinical evaluation; 2.
    How to identify relevant clinical data; 3. How to evaluate and summarize
    clinical data; 4. How to document clinical evaluation to form a clinical
    evaluation report.
    This guidance applies to medical devices and not to IVD devices.
    III Basic Principles of Clinical Evaluation
    (I) Scope of Clinical Evaluation
    The clinical evaluation comprehensively analyzes the pre-market
    and post-market clinical data (including safety, clinical performance and /
    or effectiveness data) under the applicable scope of products, including
    data on declared products and Predicate data selected by the registration
    The evaluation must confirm the adequacy of the device-related
    clinical claims, product labeling and product information (especially
    contraindications, precautions / warnings), and the suitability of the
    instructions for use.
    Define the scope of clinical evaluation based on the basic principles
    of safety and effectiveness that need to be confirmed from a clinical
    perspective, considerations including:
  6. Whether are there design features or target audiences that require
    special attention.
    The clinical evaluation shall cover all design features (such as drug
    coated devices, human or animal-derived components) that may cause
    special performance or safety concerns, the intended purpose and use of
    the device (such as target population and diseases, warnings,
    contraindications, and methods of use ) and the product safety, clinical
    performance and / or effectiveness declared by the registration application.
    The scope of clinical evaluation shall be determined based on risk
    management documents, and the two can refer to each other. Risk
    management documents identify product risks and how to deal with them.
    However, the clinical evaluation shall address the residual risks after risk
    control from the design level.
  7. Whether data from Predicates can be used to support the safety,
    clinical performance and / or effectiveness of the declared product.
    Determining whether the information of Predicates can be used for
    the clinical evaluation of declared products shall be considered from
    relevant aspects such as the applicable scope, technical and / or biological
    characteristics, etc. The applicable scope, technical and / or biological
    characteristics shall have broad similarities, but the impact of differences
    on product safety, clinical performance and / or effectiveness must be
    considered. In some cases, the similarity of these characteristics should
    preclude significant clinical differences in safety, clinical performance,
    and / or effectiveness between devices. The applicable scope of the
    devices includes the clinical status of the treatment, the severity and stage
    of the disease, the location of the human body and the patient population;
    the technical characteristics include design, technical parameters,
    physical and chemical properties (including energy intensity),
    configuration methods, key performance requirements and working
    principles; the biological characteristics include the biocompatibility of
    the material in contact with human body fluids / tissues. Annex 1 presents
    additional considerations to demonstrate the comparability. Registration
    applicants shall evaluate non-clinical supportive information, summarize
    it and include it in a clinical evaluation report. (Note: The clinical
    evaluation does not comprehensively evaluate the technical
    characteristics and biological characteristics).
  8. Be applied in data sources and data types of clinical evaluation
    Registration applicants may use data from one or more sources
    specified in Section 5. When choosing a data type, factors to be
    considered shall include product design, applicable scope and risks,
    development background of device technology (new or mature
    technology) and clinical application of mature technology. If a product is
    based on an existing mature technology and is expected to be applied in a
    mature application of that technology, its clinical evaluation is most likely
    to be accomplished through compliance with recognized standards and /
    or literature review and / or clinical experience with Predicates. High-risk
    products based on new technologies or extended applicable scope are
    more likely to require clinical trial data. Registration applicants shall
    consider the advantages and limitations of each data type.
    (II) How to Identify Relevant Clinical Data?
    When the evaluation scope is determined, the clinical evaluation
    includes three stages (see Figure 1):
  9. Identify relevant clinical data;
  10. Assess the relevance, applicability, quality, and clinical significance
    of each data set;
  11. Analyze each data set to draw conclusions about product safety,
    clinical performance and / or effectiveness, and product information
    (labels, patient instructions, and instructions for use).
    The above stages are contained in different chapters of this
    In the final stage of clinical evaluation, a clinical evaluation report
    shall be drafted to forms clinical evidence with relevant clinical data. If
    clinical evidence is not sufficient to demonstrate that the product comply
    with the basic principles of safety and performance, the registration
    applicant shall generate new data (such as conducting clinical trials and
    expanding the scope of literature searches). Therefore, clinical evaluation
    may need to be repeated.
    (III) Clinical Evaluator
    Clinical evaluations are carried out by personnel with appropriate
    experience. The registration applicant shall prove the rationality of its
    selection of the evaluator, and may refer to the qualifications and
    experience of the evaluator.
    Evaluators generally need to have the following knowledge:
  12. Device technology and its use;
  13. Methodology (clinical trial design and biostatistics); and
  14. Diagnosing and managing the expected diseases’ diagnosis and
    treatment of medical devices.