[co-author: Xun Li]
Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions published in 2016 and 2018 and took effect on May 1, 2025. The new rule is part of China's ongoing efforts to strengthen the supervision of medical device clinical trials and combat data falsification. Since 2016, the NMPA has conducted random inspections of medical device clinical trials. The NMPA has published cases of falsified trial data and revoked product registration certificates.
What is the scope of the application?
This new inspection rule applies to product registration applications under review and to approved products. For applications under review, inspection results directly affect the outcome of registration approval. For approved products, issues found during an inspection may trigger a safety assessment, risk control measures, or even revocation of the product's registration certificate.
What are the core inspection points?
Compared with earlier versions, the new inspection points consist of six categories: (a) clinical trial conditions and compliance; (b) protection of subjects' rights and interests, (c) clinical trial protocols; (d) the clinical trial implementation process; (e) traceability of trial data and clinical trial reports; (f) and management of study medical devices. There are a total of 72 inspection points.
The inspection points for in vitro diagnostic reagents have also been updated since 2016. They are divided into seven categories: clinical trial conditions and compliance; protection of subjects' rights and interests; clinical trial protocols; the clinical trial implementation process; clinical trial records; clinical trial reports; and management of experimental in vitro diagnostic reagents, as well as related reagents and instruments. There are a total of 54 inspection points.
Inspection results and legal consequences
There are four categories of inspection results: inauthenticity, serious noncompliance, normative issues, and compliance. Each category corresponds to different regulatory measures and consequences. The "serious non-compliance" category, for example, was recently added and refers to the modification of patient information or trial data, the untraceability of the study medical device or trial data, incomplete or inconsistent trial data, and the refusal to cooperate with inspections. These issues could lead to the rejection of a product registration application and, for approved products, the initiation of further safety studies and other measures. Please see the table below for details:
Cross-relevance of NMPA's inspection criteria in addressing FDA data integrity concerns
China’s NMPA inspection criteria for medical device clinical trials are relevant and useful for addressing FDA concerns over data integrity. These criteria are useful for preclinical/animal studies and human clinical data because they are based on shared core principles of data reliability, global regulatory convergence, and universal best practices in research data management. Below are examples of why these criteria are cross-relevant:
- Alignment with global data integrity principles (ALCOA+): Both the NMPA and the FDA base their data integrity requirements on the internationally recognized ALCOA+ framework. The NMPA’s clinical trial inspection criteria explicitly emphasize these principles, which are applicable to both preclinical/animal studies and human clinical data.
- Overlap in data lifecycle management: NMPA’s inspection criteria cover the entire data lifecycle — from study design to data collection, storage, analysis, and reporting — aligning with FDA concerns.
- Regulatory focus on CRO/third-party oversight: Both the NMPA and the FDA heavily regulate data from contract research organizations (CROs). The NMPA's criteria for monitoring CROs, including vendor qualification, data transfer protocols, and accountability, address FDA concerns.
- Mitigation of common data integrity risks: The NMPA's criteria target high-risk areas for data integrity failures that are universal across research types, a priority for the FDA as well. For instance, the NMPA prohibits backdating, altering results, and omitting unfavorable data.
- Convergence of global regulatory goals: Ultimately, the NMPA and the FDA share the core mission of ensuring the safety and efficacy of medical devices and drugs. Data integrity is foundational to this mission, regardless of the research phase (preclinical versus clinical) or species (animals versus humans).
Compliance recommendations
It is recommended that a full-chain compliance management system be built for clinical trials by incorporating the 2025 inspection points into daily implementation.
- Comprehensive self-inspection and rectification: Verify existing trial data, process documents, and the quality management system against the 72 medical device inspection points and 54 in vitro diagnostic reagent inspection points.
- Intensive staff training focusing on GCP and data ALCOA++ principles for investigations, clinical research associates and clinical research coordinators.
- Risk plan development: Design an emergency response process for possible nonconformities.
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