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Clinical Evaluation Report for Products that are Exempt from Clinical Trials

The clinical evaluation of medical devices refers to the process in which the registered applicant confirms whether the product meets the requirements for use or the scope of application through clinical literature, clinical experience data, clinical trials and other information.

Companies are required to conduct the clinical trials for the higher risk medical devices in China. They are divided into clinical trial and clinical verification depending on whether the risk can be controlled. The regulations on medical device and clinical trial in China have been revised and implemented from 1st Jun 2014. It may be involve long time, great effort and resources to develop the clinical trials in China.

In general, there are five main methods for clinical evaluation of medical devices in China. That is:  

  1. In the catalog of medical devices exempted from clinical trials (need to submit a comparison with a similar product registered in China)
  2. Analytical evaluation by data obtained from clinical trials or clinical application of medical devices of the same variety
  3. Adopt overseas clinical trial data
  4. Adopt real-world data
  5. Clinical trials

Which medical device is required to conduct clinical trial in China?

Class II and class III medical devices are required to develop clinical trial in China according to the “Regulations for the Supervision and Administration of Medical Devices”, only the devices designated by NMPA to be exempted from clinical trial are not required to conduct the clinical trial, but the clinical evaluation report should be submitted.

For products in the catalog of medical devices exempted from clinical trials

For the products that are in the catalog of medical devices exempted from clinical trials (hereinafter referred to as the "catalog" products), registered applicants are required to submit the comparison data of relevant information of the declared product with the contents of the Catalogue and the comparison of the declared products with the medical device in the Catalogue that has been approved for domestic registration.