Drugdu.com expert's response:

The evaluation basis for the clinical trial inspection of Class II medical devices mainly includes the following aspects:

I. Regulatory Level

Regulations on the Supervision and Administration of Medical Devices: As the basic regulation for the supervision of medical devices, this regulation stipulates the principles and requirements for the management of medical device clinical trials, serving as a crucial basis for clinical trial inspections.

Measures for the Registration and Filing of Medical Devices: It clarifies the procedures, requirements, and conditions for the registration and filing of medical devices, providing a basis for the registration-related matters involved in clinical trial inspections.

Measures for the Registration and Filing of In Vitro Diagnostic Reagents: This regulation standardizes the registration and filing of in vitro diagnostic reagents and serves as an important basis for the clinical trial inspection of Class II medical devices that are in vitro diagnostic reagents.

Quality Management Specifications for Medical Device Clinical Trials: It elaborates on the entire process of medical device clinical trials, including pre-trial preparation, safeguarding subject rights, trial design, implementation, reagent and instrument management, trial records, and trial reports, serving as the core basis for quality management in clinical trial inspections.

II. Inspection Points and Judgment Principles

Inspection Points and Judgment Principles for Medical Device Clinical Trials (Document No. YJSZJXZ [2018] No. 45): This applies to Class II medical devices that are not in vitro diagnostic reagents, clarifying the specific inspection points and judgment principles for clinical trials, including trial conditions and compliance, safeguarding subject rights, trial protocols, trial implementation, reagent and instrument management, trial records, and trial reports.

Inspection Points for Medical Device Clinical Trial Site Inspections (2016) - Part II (In Vitro Diagnostic Reagents): This serves as the technical evaluation standard for the clinical trial inspection of Class II medical devices that are in vitro diagnostic reagents, proposing detailed inspection points for each aspect of clinical trials based on the characteristics of in vitro diagnostic reagents.

III. Other Considerations

Additionally, as the regulatory policies for medical devices continue to improve and update, the evaluation basis for clinical trial inspections may also be adjusted accordingly. Therefore, when conducting clinical trial inspections, it is necessary to stay informed of the latest regulatory policies and related regulatory documents to ensure the accuracy and effectiveness of the inspection work.

In summary, the evaluation basis for the clinical trial inspection of Class II medical devices constitutes a comprehensive system, including the regulatory level, inspection points and judgment principles, and other considerations. These bases collectively form the cornerstone of clinical trial inspections, providing robust safeguards for the safety and effectiveness of medical devices.