To apply for the registration of medical devices in China, clinical evaluation shall be required. The clinical evaluation of medical devices refers to the process in which the registration applicant confirms whether the product meets the requirements for use or the scope of application through clinical literature, clinical data, clinical trials and other information.
- For all of the Class I medical devices, clinical trial is not required.
- For Class II & Class III medical devices according with the following conditions can be exempted from clinical trials:
(1) The working mechanism is clear; The design is stereotyped; The production process is mature; The medical devices of the same variety that have been on the market have been clinically applied for many years without any serious adverse event records, and the conventional use is not changed;
(2) It can be proved that the medical device is safe and effective through non-clinical evaluation (e.g. listed in ‘Medical Device Catalog Exempted from Clinical Trials’);
(3) By analyzing and evaluating the data obtained from clinical trials or clinical use of medical devices of the same variety, it can be proved that the medical device is safe and effective.
- Medical Device Exempted from Clinical Trials
The medical devices listed in ‘Medical Device Catalog Exempted from Clinical Trials’ are not required to do clinical trials.
For the medical devices listed in the ‘Medical Device Catalog Exempted from Clinical Trials’, applicants for registration must choose one similar product which has declared and marketed in Chinese market. Then the applicants should submit the relevant information of the declared similar product and a comparison of the similar product and the medical device in technical and functional aspects based on the contents of the Catalog. The specific clinical evaluation data to be submitted is as follows:
(1) Submitting the relevant information of the declared product and the contents of what mentioned in the Catalog;
(2) The similar products have been approved for medical device registration. The comparison instructions shall include the “Compared Table of Approved Medical Devices in the Declared Products and Catalogs” and the corresponding supporting materials.
The above information submitted should be able to prove that the declared product is equivalent to the product described in the Catalog. If it is not possible to prove that the declared product is equivalent to the Catalog product, the corresponding work shall be carried out in accordance with the other pathway of the clinical evaluation.