Draft Guidance for the Preparation of Product Technical Requirements and the Submission of Clinical Trial Data Released

Recently, CMDE of NMPA issued two new guidelines, including Guidelines for Registration Review of Preparation of Product Technical Requirements for Medical Devices (revised in 2021) and Guidelines for Registration Review of Data Submission Requirements for Clinical Trials of Medical Devices. Any feedback needs to be submitted by October 8, 2021 and October 10, 2021, respectively.

Product Technical Requirements (PTR)

PTR is an important basis for the registration of medical devices, which shall include the functional parameters reflecting the characteristics of the product, various performance parameters and characteristics that must be possessed or achieved to realize the intended use of the product, and the testing methods.

A PTR shall be prepared according to the latest Guidelines for Registration Review of Preparation of Product Technical Requirements for Medical Devices, national standards, industrial standards, international standards and specifications related to medical devices, and enterprise standards and special performance of products. Therefore, the new guideline is of great significance for the preparation of PTR in the future. This draft issued specifies the scope of application, basic requirements and main contents of PTR.

Clinical Trial Data 

Clinical trial data of medical devices is one of the important supporting data to evaluate the safety and effectiveness of medical devices. Standardized collection, collation, analysis and submission of medical device clinical trial data will help to improve the quality of clinical trial implementation and management, and help regulators to improve the efficiency of review. Clinical trial data of medical devices usually includes original database, analytical database, explanatory documents and program codes. The submission of clinical trial data should follow the three basic principles of authenticity, traceability and easy to read. The draft here explains scope of application, basic principles, clinical trial data and its description and submission method.

It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact info@inspirativemed.com.