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:
- In the catalog of medical devices exempted from clinical trials (need to submit a comparison with a similar product registered in China)
- Analytical evaluation by data obtained from clinical trials or clinical application of medical devices of the same variety
- Adopt overseas clinical trial data
- Adopt real-world data
- 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.
Analytical evaluation by data obtained from clinical trials or clinical application of medical devices of the same variety
The same variety of medical devices refers to the Catalog product , which has been approved for domestic registration, is basically the same as the declared product, including basic principles, structural composition, manufacturing materials (active materials are materials for contact with human body parts), production processes, performance requirements, safety evaluation, compliance with national/industry standards, intended use ,etc.
If the difference between the declared product and the medical device of the same variety does not adversely affect the safety and effectiveness of the product, it can be regarded as basically equivalent.
Before analyzing and evaluating the data obtained through the clinical trial or clinical application of the same type of medical device to prove that the medical device is safe and effective, the registered applicants firstly need to compare the declared product with one or more medical devices of the same variety to prove that the two are basically equivalent.