As a cro, these questions are asked almost every day. In the process of communicating clinical evaluation with customers, it was found that many customers were still confused with relevant concepts. Today, let's sort out our ideas and help you choose the most appropriate clinical evaluation path for your own products.

 01. Clinical evaluation requirements 

      I believe you are well aware that the classified management of medical devices in China is implemented according to the degree of risk. There are three categories in total. The first category of medical devices implements product filing management, the second and third categories of medical devices implement product registration management. Clinical evaluation shall be conducted for the registration and filing of medical devices. In the actual implementation, the clinical evaluation we are talking about mainly corresponds to the second and third types of medical devices.

 02. Definition of clinical evaluation 

      Clinical evaluation is a continuous activity that analyzes and evaluates the clinical data with scientific and reasonable methods to confirm the safety，clinical performance and /or effectiveness of the medical device within its scope of application. Generally speaking, it is to provide clinical evidence to the regulatory authorities and demonstrate to the regulatory authorities how the clinical evidence proves the compliance of products with the basic principles of safety and performance.

 03. Clinical evaluation path 

      The evidence of clinical evaluation mainly comes from clinical trial reports, clinical literature and clinical data of clinical experience.

      According to the requirements of current regulations, different clinical data sources mean different clinical evaluation paths. According to the product characteristics, clinical risks and available clinical data, there are three clinical evaluation paths:

      ① Path of exemption from clinical evaluation: Class II and class III medical devices listed in the catalogue of medical devices exempted from clinical evaluation;

      ② Through the analysis and evaluation of the clinical literature and clinical data of the same kind of medical devices;

      ③ Clinical trial path: including domestic clinical trials, all or simultaneous clinical trials abroad;

      Many times, the clinical evaluation we are talking about actually refers to point 2 above. If your product is not listed in the list of medical devices exempted from clinical evaluation, you will face the above two or three ways.

 04. Medical device clinical trial decision 

      The State encourages registration applicants to use the most effective way to obtain the minimum amount of information necessary to prove compliance with the basic principles of safety and performance of medical devices, so as to eliminate or reduce unnecessary burden, so that patients can obtain safe and effective medical devices as soon as possible and continuously.

      The necessity of clinical trials should fully consider the scope of application, technical characteristics, biological characteristics, risk degree, and differences with existing medical devices or existing diagnosis and treatment methods of medical devices. If the results of non clinical studies and / or existing clinical data are insufficient to prove the conformity of the product to the basic principles of safety and performance of medical devices, clinical trials may be required. The clinical trial decision of medical devices can consider the following situations according to the product conditions:

"Is it a high-risk medical device?

  Is it a new medical device?

  Can non clinical research data prove that the product conforms to the basic principles?

  Are there any previous products?

  Are the previous generation products approved for listing in China?

      To judge whether a clinical trial is required according to the condition of the medical device, you can press the QR code to understand the decision-making flow chart of the clinical trial of the medical device.

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