Medical Devices equipment clinical trials refer to verifying whether the medical devices equipment's theoretical principles, basic structure, performance and other elements can ensure safety and effectiveness through clinical use. Simply put, the purpose of clinical trials of Medical Devices equipment is to evaluate whether the tested product has the expected safety and effectiveness.
As early as the 2004 edition of the "Medical Devices equipment clinical trial regulations" (Bureau Order No. 5), the third clause clearly defined: The medical devices equipment clinical trials mentioned in these regulations refer to the medical institutions that have obtained the medical devices equipment clinical trial qualifications (Hereinafter referred to as medical institutions) The process of trial or verification of the safety and effectiveness of Medical Devices equipment applied for registration under normal conditions of use in accordance with regulations.
Now let's take a look again, what is clinical immunity? What is the legal basis for clinical exemption?
Article 22 of Chapter 4 of the "Administrative Measures for the Registration of Medical Devices Equipment" (Order No. 4 of the State Food and Drug Administration) promulgated on July 30, 2014, clearly stipulates the following:
One of the following circumstances can be exempt from clinical trials:
(1) The working mechanism is clear, the design is finalized, the production process is mature, the medical Devices equipment of the same variety that has been marketed has been clinically used for many years, has no record of serious adverse events, and does not change the routine use;
(2) It can be proved that the Medical Devices equipment is safe and effective through non-clinical evaluation;
(3) The safety and effectiveness of the medical devices equipment can be proved by analyzing and evaluating the data obtained from clinical trials or clinical use of the same type of Medical Devices equipment.
The list of Medical Devices equipment exempt from clinical trials is formulated, adjusted and published by the State Food and Drug Administration.
For products that are not included in the catalog of Medical Devices equipment exempt from clinical trials, through analysis and evaluation of the data obtained from the clinical trials or clinical use of the same type of Medical Devices equipment, it can be proved that the Medical Devices equipment is safe and effective. Explain when applying for registration and submit relevant supporting materials.