In accordance with the provisions of the regulations on Supervision and Administration of Medical Devices, applications for the registration of medical devices of the second and third categories shall submit clinical evaluation materials, Although the amendment to the regulations on Supervision and Administration of Medical Devices (draft) (hereinafter referred to as "the Amendment") mentions that the second type of medical device may in principle no longer carry out clinical evaluation, however, since the amendment is still in the stage of being submitted for trial, Therefore, the clinical evaluation of medical devices is still one of the necessary data in the process of medical device registration.
Definition and working objective of Clinical Evaluation of Medical Devices
Among the many medical device registration data, the clinical evaluation data has higher uncertainty and investment risk than other registration data. Therefore, most registration applicants pay particular attention to the implementation of clinical evaluation. In this paper, the author will discuss the clinical evaluation of medical devices for peer reference. Before carrying out the clinical evaluation of medical devices, the first question that needs to be clear is what is the clinical evaluation of medical devices and the working objectives of clinical evaluation of medical devices. According to the definition of "Technical guidelines for Clinical Evaluation of Medical Devices" (hereinafter referred to as "guiding principles"), clinical evaluation of medical devices refers to the applicant for registration through clinical literature, clinical experience data, The process by which information such as clinical trials confirms whether the product meets the requirements or scope of application. Therefore, the objective of clinical evaluation of medical devices is to confirm and verify the intended use or scope of application of the declared product, and to answer the question whether the product can be used for a certain purpose or for a certain population. Instead of answering the question "what kind of disease the product might apply to or to what population." This requires applicants for registration to have a clear understanding of the intended use and scope of application of the declared product before conducting a clinical evaluation. If the intended use or scope of application of the declared product is not clear, It is suggested to carry out exploratory research on the declared products to clarify the intended use of the products. Exploratory research can be used as a part of clinical evaluation of medical devices, but it is not the main content of clinical evaluation of medical devices.
Approach to Clinical Evaluation of Medical Devices
In accordance with the definition and relevant requirements of clinical evaluation of medical devices in the guiding principles, the medical devices registered and declared within the territory of China, There are three main ways of clinical evaluation: the inclusion of the list of Medical Devices exempted from Clinical trial (hereinafter referred to as the exemption catalogue) for clinical evaluation (that is, the exemption pathway). The data obtained from clinical trials or clinical use of medical devices of the same variety were analyzed and evaluated (i.e. the same variety approach) and the clinical trials of medical devices. Although the choice of clinical evaluation approach is one of the most important issues for registration applicants, regardless of which way they choose, the goal of clinical evaluation is the same. This is to confirm and verify the expected use or scope of application of the declared products, and to discuss the ways of exemption and the same variety of ways to evaluate the clinical application of medical devices.
The clinical evaluation of medical devices is a systematic work. Because its clinical application is often finalized in the design and development stage, the clinical evaluation of medical devices should be considered from the perspective of the design and development of medical devices. According to the inherent characteristics of the product, it is the key to write the clinical evaluation report of the medical device to formulate the corresponding evaluation strategy and demonstration direction.