Chapter 4: Clinical Evaluation Data (临床评价资料)

NMPA Reference: Notice 2021-121, Attachment 5, Chapter 4
Document Code: NMPA-CH4
Responsible Party: Manufacturer (CRO supports clinical strategy and evaluation)

Requirements Checklist

4.1 Table of Contents

[ ] All headings and sub-headings with page numbers

4.2 Clinical Evaluation Data Requirements (临床评价资料要求)

4.2.1 Product Description and R&D Background

[ ] Basic device information
[ ] Intended use
[ ] Existing diagnostic or treatment methods and related medical device clinical applications
[ ] Relationship between the device and existing methods
[ ] Expected clinical outcomes

4.2.2 Scope of Clinical Evaluation

[ ] Define which aspects of the device are covered by clinical evaluation
[ ] For parts exempt from clinical evaluation: describe structure/composition and justify exemption

4.2.3 Clinical Evaluation Pathway Selection

Select the appropriate pathway based on intended use, technical characteristics, and existing clinical data:

Pathway 1: Equivalent Device (同品种临床评价路径)

[ ] Comparison of intended use between subject and equivalent device
[ ] Comparison of technical characteristics
[ ] Comparison of biological characteristics
[ ] Collection, evaluation, and analysis of clinical data from equivalent device(s) to form clinical evidence
[ ] For identified differences: scientific evidence demonstrating equivalent safety and efficacy

Pathway 2: Clinical Trial (临床试验路径)

[ ] Clinical trial protocol (方案)
[ ] Ethics committee approval from each trial institution
[ ] Clinical trial report (报告)
[ ] Informed consent form template
[ ] Clinical trial database (raw database, analysis database, documentation, program code)
- File formats: PDF, Word (editable), Excel, XPT, TXT as appropriate

Pathway 3: Exemption from Clinical Evaluation (免于临床评价)

[ ] Product is listed in the "Medical Device Catalogue Exempt from Clinical Evaluation"
[ ] Comparison with exempt catalogue product per NMPA Guidance Principles
[ ] Demonstrate equivalence in: basic principle, structure, performance, safety, intended use

4.3 Other Data

[ ] Summary, report, and data for applicable evaluation items (if applicable)

Clinical Evaluation Pathways -- Decision Flowchart

Is the device on the Clinical Evaluation Exemption List?
  |
  YES --> Pathway 3: Prepare comparison documentation per guidance
  |
  NO --> Is a suitable equivalent (同品种) device available?
           |
           YES --> Can differences be scientifically justified?
           |         |
           |         YES --> Pathway 1: Equivalent device evaluation
           |         |
           |         NO --> Pathway 2: Clinical trial required
           |
           NO --> Pathway 2: Clinical trial required

Comparison with EU MDR

Aspect	NMPA Ch.4	EU MDR (Article 61, Annex XIV)
Pathways	3: Equivalent / Clinical Trial / Exemption	CEP+CER+PMCF (all classes; equivalence per Annex XIV)
Equivalence	同品种 comparison (technical, intended use, biological)	Technical, biological, clinical equivalence (Annex XIV, Part A)
Exemption	Published exemption list for Class II/III	No exemption mechanism (all devices require CE)
Trial requirements	Protocol + Ethics + Report + Informed Consent + Database	Similar + CIP per Annex XV
Post-market clinical	Not part of registration dossier (separate PMS system)	PMCF mandatory, integrated into CER updates
Class I	Registration only, no clinical evaluation	Still requires clinical evaluation (proportionate)
Literature review	Part of equivalent device pathway, no standalone literature pathway	Standalone literature review pathway available

Key Standards & References

Notice 2021-121, Attachment 5, Chapter 4
Administrative Measures for Medical Device Clinical Trial (Order No. 4, 2023 Revision)
Guidance Principles for Clinical Evaluation of Medical Devices (通用指导原则)
List of Medical Devices Exempt from Clinical Evaluation (updated periodically)
Guidance Principles for Clinical Evaluation via Equivalent Device (同品种临床评价指导原则)
GB/T 42062-2022: Risk management (for clinical risk context)

Chapter 4: Clinical Evaluation Data (临床评价资料) ​

Requirements Checklist ​

4.1 Table of Contents ​

4.2 Clinical Evaluation Data Requirements (临床评价资料要求) ​

4.2.1 Product Description and R&D Background ​

4.2.2 Scope of Clinical Evaluation ​

4.2.3 Clinical Evaluation Pathway Selection ​

4.3 Other Data ​

Clinical Evaluation Pathways -- Decision Flowchart ​

Comparison with EU MDR ​

Key Standards & References ​