Drugdu.com expert's response:

The evaluation criteria for the inspection of clinical trials for Class II medical devices primarily encompass three levels: regulations, technical specifications, and specific inspection points, as detailed below:

I. Regulatory Basis: Establishing the Top-Level Framework for Inspections

Medical Device Supervision and Administration Regulations

As the foundational legislation for medical device regulation, it clarifies the management principles for clinical trials, including core requirements such as trial design, subject protection, and data authenticity, providing a legal basis for inspections.

Medical Device Registration and Filing Administration Measures

This regulates the medical device registration process, emphasizing clinical trials as a critical component of registration applications. It mandates that clinical trial data submitted must be authentic, complete, and traceable, offering procedural guidance for inspections.

In Vitro Diagnostic Reagent Registration and Filing Administration Measures

Specifically tailored to Class II in vitro diagnostic reagent medical devices, this refines special requirements for clinical trials, such as sample size, testing methods, and control settings, ensuring targeted inspections.

II. Technical Specifications: Defining Quality Management Standards

Good Clinical Practice (GCP) for Medical Device Clinical Trials

This comprehensively outlines the management of the entire clinical trial process, including:

Pre-trial Preparation: Ethical review, protocol development, and investigator training.

Subject Protection: Informed consent, privacy protection, and risk-benefit assessment.

Trial Implementation: Blinding design, data recording, and adverse event reporting.

Data Management: Electronic data capture, source data verification, and statistical analysis.

GCP serves as the core standard for inspections, ensuring scientific rigor and ethical compliance in trials.

III. Inspection Points: Refining Specific Inspection Criteria

General Inspection Points

Authenticity: Strictly prohibits the fabrication of subject information, trial data, or the use of counterfeit medical devices.

Serious Non-compliance: Includes modifications to critical data, lack of sample traceability, and refusal to cooperate with inspections.

Regulatory Compliance: Issues arising from non-strict adherence to GCP that do not impact safety or efficacy evaluations.

Category-Specific Inspection Standards

In Vitro Diagnostic Reagents: Based on Part II of the "Inspection Points for On-site Inspections of Medical Device Clinical Trials (2016)," focusing on analytical performance, clinical sensitivity/specificity, etc.

Non-In Vitro Diagnostic Reagents: Guided by the "Inspection Points and Determination Principles for Medical Device Clinical Trials" (NMPA Document No. 45, 2018), covering trial conditions, subject protection, protocol execution, and record reporting.

Dynamic Updates

In 2024, the NMPA released the "Draft Inspection Points and Determination Principles for Medical Device Clinical Trial Projects," aiming to further unify inspection scopes and determination standards. For instance, it proposes strengthening data security oversight and clarifying adverse event reporting timelines, reflecting a trend towards stricter regulation.

IV. Inspection Process and Outcome Determination

Inspection Authority: Provincial-level drug regulatory departments organize inspection teams (e.g., Tianjin Medical Device Clinical Inspectors) to conduct on-site inspections based on the aforementioned criteria.

Outcome Classification:

Pass Inspection: No authenticity or serious non-compliance issues identified.

Rectification and Re-inspection: Regulatory compliance issues present, requiring rectification within a specified timeframe and submission of a report.

Fail Inspection: Authenticity or serious non-compliance issues identified, resulting in the denial of product registration.

V. Practical Significance

Safeguarding Public Health: Ensuring the safety and efficacy of marketed medical devices through rigorous inspections.

Promoting Industrial Upgrading: Driving enterprises to enhance R&D and production standards, eliminating low-quality products.

Optimizing Medical Insurance Policies: Products that pass inspections gain advantages in medical insurance reimbursement and procurement, improving accessibility.