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.
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.
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.
Overseas Clinical Trial Data
The research data generated in the process of confirming the safety and effectiveness of medical devices to be registered in China under normal use conditions in clinical trial institutions with the requirements of the country (region) where the clinical trial is conducted.
Overseas clinical trials need to comply with the relevant regulations of overseas clinical trials and are carried out in countries (regions) with clinical trial quality management and also meet the regulatory requirements for clinical trials of medical devices (including in vitro diagnostic reagents) in China.
The overseas clinical trial materials submitted by the applicant shall include at least: clinical trial protocol, ethical opinions, and clinical trial report. The clinical trial report should include analysis and conclusions of the complete clinical trial data.
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.