The NMPA Center for Medical Device Evaluation (CMDE) issued the “Pre-Review of Clinical Trial Protocols for Innovative Medical Devices” on March 13, 2026. This initiative allows applicants for innovative devices to request a pre-review of their clinical trial protocols through the established communication channel for major technical issues. The feedback provided during this pre-review serves as a crucial reference for the subsequent technical evaluation process.
Click HERE for the translated document of Innovation Device Approval Procedure
Click HERE for the detailed Implementation Rules for the Special Review of Innovative Medical Devices issued in April 2025
For our comprehensive analysis on the latest innovative devices approvals, click HERE
Highlights of Clinical Protocol Pre-Review
The key points of the notice are as follows:
Application Process: Applicants must submit their request for a clinical trial protocol pre-review via the CMDE’s communication pathway for significant technical issues in innovative products. The submission title should clearly state it as a “Pre-review of Clinical Trial Protocol for [Product Name].”
Prerequisites for Application: A pre-review request should only be submitted after necessary non-clinical research and, if applicable, clinical feasibility studies are completed. The clinical trial protocol itself must be scientifically robust, developed with full consideration of the product’s specific characteristics, potential clinical risks, and any existing clinical data.
Required Documentation: Submissions must include a comprehensive set of documents as detailed in the notice’s appendixes, detailed below. These materials should clearly explain the product’s intended use, its working principle or mechanism of action, its structural composition and key materials, and confirm its critical functional and performance parameters. The goal is to demonstrate that the anticipated clinical risks are acceptable.
CMDE Review Process:
– If the submitted materials are deemed insufficient, the CMDE will inform the applicant, typically via video conference, of the deficiencies and necessary supplementary research. The pre-review cannot proceed until a new application with the required information is submitted.
– If the submission meets the requirements, the CMDE will proceed with the pre-review. This may involve organizing expert consultation meetings, where the applicant is expected to participate and present detailed information on the product’s design and the proposed clinical trial.
Pre-review Opinion: The CMDE will issue a pre-review opinion on the clinical trial protocol or its design elements based on current scientific understanding and clinical consensus. While it is strongly recommended that applicants conduct their trials in accordance with this opinion, any protocol adjustments should be carefully considered for the increased risks and uncertainties they may introduce.
Significant Product Changes: If the product’s design or technical characteristics undergo significant changes after the pre-review (without affecting its innovative status), a new pre-review is recommended.
Nature of the Opinion: The pre-review opinion is intended to guide applicants in scientifically sound clinical trial design and is not a formal technical evaluation conclusion.
Requirements for Medical Devices & IVDs Protocol Pre-Review
The notice includes two appendices with specific documentation requirements.
Appendix 1: Requirements for Innovative Medical Devices
This appendix lists the required documents for medical devices, which are analogous to those for IVDs but tailored for devices. Key requirements include:
– A rationale detailing the development basis, expected clinical benefits and risks, and a comparison with existing treatment or diagnostic methods.
– Product instructions covering intended use, mechanism of action, structural composition, and key performance parameters.
– Research data confirming main functions, performance, and structural components, including results from bench and/or animal tests where applicable.
– A clinical trial protocol compliant with relevant quality management standards.
– Supporting documentation justifying key trial design elements, such as control group selection, endpoints, and follow-up duration.
– An overview of similar products approved in other countries/regions, along with a comparative analysis.
Appendix 2: Requirements for Innovative IVDs
This appendix outlines the necessary documents for IVD clinical trial protocol pre-review, including:
– A detailed rationale for the product’s development, especially the choice of the marker and its correlation with the target condition.
– The product instructions covering key elements like intended use, test principle, and interpretation of results.
– Research data confirming the product’s design, performance indicators, and complete cut-off value studies.
– A clinical trial protocol compliant with relevant quality management regulations.
– Supporting documentation for all critical elements of the trial design.
– An overview of similar products approved domestically and internationally, including a comparison with the submitted product.