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.
Good-quality real-world data is the basis for real-world research and directly affects the strength of evidence generated by real-world research. Real-world data quality evaluation requires attention to the relevance and reliability of data on the basis of following ethical principles, complying with regulatory requirements, and ensuring data security.
When real-world data is used for clinical evaluation of medical devices, planning and design should be based on specific research purposes, follow ethical principles, comply with regulatory requirements, and ensure data security.