Drugdu.com expert's response:

The selection of clinical evaluation pathways for Class II active medical devices should be based on product risk levels, technical characteristics, and data availability, with evaluations completed through three pathways: exemption from clinical trials, comparison with predicate devices, or clinical trials. The specific analysis is as follows:

I. Core Pathway Selection Criteria

Exemption from Clinical Trials Pathway

Applicable Conditions: The product is listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation and fully aligns with the descriptions in the catalogue.

Key Operational Points: Submit comparative data between the product and the catalogue entries, along with a comparison statement with legally marketed medical devices already approved in China (covering fundamental principles, structural composition, performance requirements, etc.) to demonstrate equivalence.

Typical Examples: Low- to moderate-risk products such as general surgical instruments and certain rehabilitation aids.

Comparison with Predicate Devices Pathway

Applicable Conditions: The product is essentially equivalent to a legally marketed predicate medical device in terms of fundamental principles, structural composition, manufacturing materials, and performance requirements, with differences that do not affect safety and effectiveness.

Key Operational Points: Select a legally marketed predicate device approved in China as the comparator, prioritizing products with identical intended uses and similar technical characteristics.

Submit a detailed comparative analysis report covering key aspects such as fundamental principles, structural composition, and performance indicators, assessing the impact of differences on safety and effectiveness.

Utilize non-clinical data (e.g., laboratory studies, animal experiments), clinical literature, or clinical experience data to validate the differentiated aspects.

Typical Examples: Active devices such as cardiac pacemakers and artificial ventilators, which complete evaluations by comparing performance parameters and clinical data with legally marketed products.

Clinical Trials Pathway

Applicable Conditions: The product falls into a high-risk category (e.g., innovative technologies, novel intended uses). Safety and effectiveness cannot be demonstrated through exemption or comparison with predicate devices. The申报 (to be submitted) product or key components feature new technologies (e.g., novel materials, new mechanisms of action).

Key Operational Points: Design the trial protocol in strict accordance with the Good Clinical Practice for Medical Devices, clarifying trial objectives, evaluation criteria, sample size, etc. Submit complete documentation, including ethics committee approval, informed consent forms, and clinical trial reports. Ensure trial design adheres to the Guiding Principles for Clinical Trial Design of Medical Devices to guarantee scientific rigor and ethical compliance.

Typical Examples: High-risk products such as novel electrical stimulation therapy devices and intelligent prosthetics.

II. Key Decision Factors for Pathway Selection

Product Risk Level

High-risk products (e.g., implantable devices, life-support systems) typically require clinical trials to verify safety and effectiveness.

Low- to moderate-risk products may prioritize exemption or comparison with predicate devices.

Technical Characteristics and Data Availability

If the product is highly similar in technical characteristics to a legally marketed predicate device and supported by sufficient clinical data, comparison with predicate devices is an efficient choice.

If the product incorporates innovative technologies or novel intended uses, clinical trials are necessary to obtain direct evidence.

Regulatory Requirements and Review Standards

Review centers in different provinces may vary in authorization requirements for comparison with predicate devices and the rigor of performance comparison data. Early communication is advised.

For example, some provinces require detailed biocompatibility testing data for orthopedic implant comparisons.

III. Practical Recommendations for Optimizing Pathway Selection

Early Planning and Communication

Review the clinical evaluation pathway recommendations issued by the National Medical Products Administration (NMPA) during early product development to clarify product classification and evaluation requirements.

Engage in pre-submission communications with review centers to understand province-specific review standards and avoid supplementary submissions or rejections due to insufficient documentation.

Scientific Design of Comparative Analysis

For comparison with predicate devices, ensure reasonable comparator selection and comprehensive comparison items (e.g., performance parameters, clinical literature, adverse event data).

Present differences and validation evidence in a tabular format to enhance review efficiency.

Leveraging Overseas Data

If the product is legally marketed in developed countries such as the EU or U.S., overseas clinical data may be submitted in accordance with the Guiding Principles for Acceptance of Overseas Clinical Trial Data of Medical Devices, provided the data are applicable to the Chinese population and healthcare environment.

For example, a骨科 (orthopedic) implant manufacturer accelerated registration by submitting EU clinical trial data combined with subgroup analyses of the Chinese population.

Addressing Special Requirements for Traditional Chinese Medicine (TCM) Medical Devices

Active TCM devices (e.g., meridian detectors, pulse diagnostic instruments) must integrate evidence from TCM theory, human experience, and clinical trials, reflecting the principle of syndrome differentiation and treatment.

Incorporate TCM-specific indicators such as syndrome scores and pulse changes into clinical evaluations, while referencing testing results from legally marketed TCM diagnostic devices.