Checkpoints Reveal How NMPA Inspects Your Clinical Trials

NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” on March 12, 2025. The trial version was released in June 2024.

For an English copy of the Inspection Checkpoints and Judging Principles for Clinical Trial, please email us at info@ChinaMedDevice.com.

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Highlights of the Inspection Checkpoints

The Medical Device Clinical Trial Inspection Guideline provides a comprehensive framework for evaluating the quality and compliance of clinical trials for medical devices and in vitro diagnostic reagents (IVDs). It focuses on ensuring the integrity of trial data, safeguarding participant rights, and maintaining regulatory compliance. The guideline is divided into six sections for medical devices (72 items) and seven sections for IVDs (54 items), covering key areas such as trial conditions, participant rights, trial protocols, implementation processes, data traceability, and device management.

Key highlights include:

1. Trial Conditions and Compliance: Ensures trials are conducted in qualified, registered institutions with appropriate ethical approvals, investigator qualifications and device quality compliance. It mandates proper documentation, including trial protocols, informed consent forms, and investigator training records.
2. Participant Rights Protection: Emphasizes ethical review processes, informed consent procedures, and the use of the latest approved documents. It requires re-consenting participants if trial documents are updated.
3. Trial Protocol Adherence: Stresses the importance of following approved protocols, ensuring consistency across multi-center trials, and documenting any deviations.
4. Trial Implementation: Details participant screening, randomization, follow-up procedures, and handling of adverse events (AEs) and serious adverse events (SAEs). It requires timely reporting of SAEs and proper documentation of safety information.
5. Data Traceability and Reporting: Mandates accurate, complete, and traceable data recording. It emphasizes the use of electronic data systems with proper validation, audit trails, and source data verification. Any data modifications must be justified and documented.
6. Device Management: Ensures proper handling, storage, and usage of trial devices, with detailed records of transportation, distribution, and reconciliation.

The guideline classifies inspection findings into authenticity issues (e.g., data falsification), serious non-compliance (e.g., untraceable data), normative issues (procedural gaps), and compliance. This structured approach ensures rigorous oversight, enhances trial quality, and aligns with global regulatory standards, ultimately safeguarding participant safety and data reliability.

Differences between the Final and Trial Version

The final version emphasizes data integrity, patient safety, and operational rigor, reflecting lessons from the trial phase and aligning with evolving regulatory expectations.

Structural Adjustments

• The final version emphasizes clinical trial execution, data traceability, and compliance. It divides checkpoints into six categories for medical devices (72 items) and seven for IVDs (54 items), with clearer subsections (e.g., “Clinical Trial Conditions and Compliance,” “Data Traceability”).

Expanded Scope

• The final version introduces new requirements for electronic data management (e.g., validated systems, audit trails), blinded trials, and emergency unblinding procedures.
• It adds detailed criteria for safety reporting (e.g., SAE timelines, risk-benefit analysis) and trial device management (e.g., transport, storage, reconciliation).

Refined Judgment Principles

• The final version adopts stricter classifications: “authenticity issues” (e.g., data falsification), “serious non-compliance” (e.g., non-traceable data), “normative issues” (procedural gaps), and “compliance.” This enhances clarity for regulatory actions.

Enhanced Specificity

• The final version clarifies documentation standards (e.g., electronic signatures, version control) and source data requirements (e.g., alignment between CRFs and medical records).
• It mandates multi-center consistency (e.g., uniform protocol versions across sites) and sample traceability (e.g., unique identifiers for IVD trials).

Regulatory Alignment

• The final version strengthens references to GCP principles and integrates updates from newer regulations, such as requirements for third-party laboratory certifications and post-approval monitoring.