On November 28, 2023, NMPA released the Medical Device Clinical Trial Inspection Points and Judgment Principles (Draft) asking for feedback. The guideline aims to enhance the quality of medical device clinical trial inspections, establish uniform inspection criteria, and align with relevant regulations, including the "Medical Device Supervision and Management Regulations" and "GCP for Medical Device Clinical Trials".
Inspection Objectives:
The primary goal is to assess the adherence of clinical trial implementation, data recording, and result reporting to trial protocols and regulatory standards. It ensures the compliance of the trial process, verifies the authenticity and completeness of submitted data, and prioritizes the rights and safety of participants.
Scope of Application:
Applicable to on-site inspections of medical device clinical trials initiated by the NMPA, the guideline extends to inspections organized by the Food and Drug Inspection and Testing Center of the NMPA. Provincial MPA departments are expected to adopt the guideline for on-site inspections within their jurisdictions.
Key Inspection Contents:
The guidance outlines inspection points across six areas for general medical device clinical trials and seven for IVD reagent clinical trials. Topics include trial conditions, participant rights protection, trial protocols, implementation processes, data traceability, and medical device trial management.
Principles for Determining Results:
Inspection outcomes depend on verification of original records and data. Authenticity issues, including data fabrication or unjustified changes, prompt identification. Non-compliance arises when the clinical trial process violates regulatory requirements. If neither authenticity nor compliance issues are detected, the trial is considered compliance.
Two appendixes are included in this guidance, the first one is "Key Points for General Medical Device Clinical Trials". It contains 72 key points addressing issues such as data manipulation, use of substitute devices, and intentional data damage in general medical device clinical trials. Appendix 2 is "Key Points for IVD Reagent Clinical Trials". It contains 52 key points, focusing on key aspects of IVD reagent clinical trials, including trial conditions, participant rights protection, trial protocols, implementation processes, and data traceability.
If you have any feedback, please email me before Dec 31, 2023. I can help you submit to NMPA.
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Grace Fu
China Med Device, LLC
gpalma@ChinaMedDevice.comPhone US: (978) 390-4453
Phone China: 18201749732
www.ChinaMedDevice.com------------------------------