Revised Medical Device Clinical Trial Inspection Points Released by NMPA

New Medical Device Clinical Trial Inspection Key Points and Judgment Principles have been issued by China's National Medical Products Administration (NMPA) on March 12, 2025. They will take effect on May 1, 2025. The formal announcement is accompanied by a Policy Interpretation from NMPA issued on the same day.

The Guidance supersedes and repeals 2 older guidance documents from 2016 and 2018: the Notice of the Food and Drug Administration on Carrying out the Supervision and Random Inspection of Clinical Trials of Medical Devices (No. 98 of 2016) and the Notice of the General Department of the State Food and Drug Administration on Printing and Distributing the Key Points and Judgment Principles of Clinical Trials of Medical Devices (Yao Jian Zongyi Note [2018] No. 45).

The newly issued principles outline the purpose and scope of medical device clinical trial project inspections, specify inspection points for medical device and IVD reagent trials, and establish unified judgment criteria. The checklist for medical device trials has six sections with 72 inspection points, while the IVD reagent trial checklist has seven sections with 54 points. Results are categorized into four scenarios: authenticity issues, serious non-conformities, compliance issues, and conformity.

Interpretation of Key Points in the Medical Device Clinical Trial Project Inspection Points and Judgment Principles

1. Purpose and Scope

The primary objective of medical device clinical trial project inspections is to evaluate whether trial implementation, data recording, and result reporting comply with the trial protocol and relevant medical device clinical trial requirements. This ensures the standardization of the trial process, verifies the authenticity, integrity, accuracy, and traceability of submitted documents, and safeguards the rights and safety of trial participants. These inspection points apply to on-site inspections of medical device clinical trials initiated by the NMPA and organized by its designated unit. Local drug regulatory departments follow these points for inspections within their jurisdictions.

2. Inspection Points

The Medical Device Clinical Trial Project Inspection Points cover six areas with 72 points, while the IVD Reagent Clinical Trial Project Inspection Points cover seven areas with 54 points.

3. Judgment Principles for Inspection Results

Inspection results are categorized into four types:

• Authenticity Issues: Fabricating information on trial participants, samples, devices, trial processes, or research data; substituting devices; concealing or selectively using data; concealing serious adverse events or device defects.
• Serious Non-Conformities: Modifying critical data affecting safety and efficacy; key trial activities or data not traceable; incomplete, inaccurate, or inconsistent data; refusing inspection.
• Compliance Issues: Trials not meeting regulatory requirements but without significant impact on safety and efficacy.
• Conformity: No issues found.

Core Changes in the 2025 Version of the Medical Device Clinical Trial Project Inspection Points and Judgment Principles Compared to the 2018 Version

1. Inspection Purpose

The 2025 version emphasizes compliance and data authenticity, integrity, accuracy, and traceability.

2. Inspection Points Content

The 2025 version divides the clinical trial implementation process into three parts: participant screening, protocol execution, and safety information handling, with more detailed and specific descriptions.

3. Judgment Principles

The 2025 version specifies that concealing data, selective data use, and intentional data destruction or concealment are authenticity issues. It also outlines serious non-conformities such as data modification affecting safety and efficacy, data inconsistencies, and non-cooperation during inspections.

4. On-Site Inspection Points

• Clinical Trial Conditions and Compliance: The 2025 version has stricter requirements for ethical review, clear timelines for ethical approval and contract signing, and detailed filing procedures. It also emphasizes that inspection reports should include maintenance, calibration, and verification records for trial-related instruments and equipment.
• Participant Rights Protection: The 2025 version stresses obtaining ethical approval for protocol revisions and consent form updates and introduces the role of a "fairness witness."
• Clinical Trial Protocol: The 2025 version requires the chief investigator's signature and date on the protocol, along with official seals and signatures from the sponsor.
• Clinical Trial Implementation: The 2025 version emphasizes adherence to inclusion/exclusion criteria, proper randomization timing, and documentation of missed follow-ups or procedures.
• Clinical Trial Records: The 2025 version introduces the ALCOA+ standard for data authenticity and traceability, requiring retention of source data and key process documents in various formats.

Challenges and Response Strategies for International Companies under the 2025 Version of the Medical Device Clinical Trial Project Inspection Points and Judgment Principles

1. Authenticity Issues

• Challenge: Authenticity issues are classified as the highest risk, potentially leading to rejection of registration applications or revocation of approved products.
• Strategy: Collaborate with compliant and experienced local advisors or teams familiar with Chinese medical device clinical trial regulations.

2. Data Traceability

• Challenge: The 2025 version imposes stricter requirements on data traceability.
• Strategy: Use EDC systems compliant with ALCOA+ principles and conduct regular third-party audits to ensure data consistency and reduce inspection risks.

3. Regulatory Differences

• Challenge: Differences between Chinese regulations and international markets (e.g., FDA, CE) require additional resources for compliance.
• Strategy: Engage local experts or regulatory teams familiar with Chinese requirements to ensure trial compliance.

4. Contract and Documentation Management

• Challenge: The 2025 version has stricter requirements for contract signing and document management.
• Strategy: Implement rigorous document management systems to track and retain all necessary documents and materials, ensuring timely and accurate submissions.

5. Training and Qualifications

• Challenge: The 2025 version specifies detailed training requirements for investigators.
• Strategy: Develop comprehensive training programs covering trial protocols, device handling, and regulatory requirements, ensuring completion before investigators assume their roles.

6. Adverse Event Reporting

• Challenge: The 2025 version emphasizes adverse event reporting and documentation.
• Strategy: Establish robust adverse event monitoring and reporting mechanisms to ensure timely and accurate reporting and maintain complete records for inspection readiness.

Further Information

Read the original announcements about the updated inspection principles for medical device clinical trials and the policy interpretation by the NMPA. Cisema can help with running a compliant clinical trial in China. Please contact us if you would like to learn more.

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