How medical devices are exempted from clinical trials
1. In the catalog of medical devices exempted from clinical trials
(1) Submitting the comparison data of the relevant information of the declared product with the contents of the Catalogue.
(2) Submitting a comparison between the declared product and the medical device in the Catalogue that has been approved for domestic registration. The comparative description shall include the "Comparison Table of the Declared Product and the Domestic Registered Medical Devices in the Catalog" and corresponding supporting materials.
The above information submitted should be able to prove that the declared product is equivalent to the product described in the Catalogue. If it cannot be proved, the corresponding work shall be carried out in accordance with the other requirements.
2. Analytical evaluation by data obtained from clinical trials or clinical application of medical devices of the same variety
The case where this method can be used:
1) The company already has similar products on the market. And the product is completely consistent with the functional principle and scope of application of the similar products already on the market.
2) The cross-provincial migration of the production address of domestic enterprises involves the change of company name, and this company produces the same product that is not exempted from clinical trials after migration.
3) The products between different subsidiaries or branches under the same group company are identical or similar.
4) Overseas companies have already registered their products in China. And after a few years, they need to re-establish production bases in China to produce the same products.
5) The continuation of the products that have been registered has not been successful (and has not been vetoed due to factors such as backward technology, unstable performance, and clinical insecurity), and reapply for the continuation.
6) It is the company's first such product, but can obtain authorization from other companies to obtain clinical trial data.
7) The same product changes from a low class to a high class due to regulatory changes, which requires a re-registration.
3. Overseas clinical trials data
Basic principles for accepting data from overseas clinical trials:
1) Principle of ethic
Overseas clinical trials should follow the ethical guidelines established by the Helsinki Declaration of the World Medical Congress. Applicants are also required to state the ethics, laws, regulations, and established norms and standards, or international norms and standards, in the country (region) where the clinical trial is conducted.
2) Principle of legal
Overseas clinical trials should be carried out in countries (regions) that have quality management of clinical trials, and comply with the regulatory requirements for clinical trials of medical devices (including in vitro diagnostic reagents) in China. If there are differences, the differences should be explained in detail and fully demonstrated that the differences do not affect the authenticity, scientificity, reliability and traceability of the research result, and can protect the rights and interests of the subjects.
3) Principle of scientific
Overseas clinical trial data should be authentic, scientific, reliable, and traceable. Applicants should provide complete test data which has not been screened.
Considerations and technical requirements when receiving data from overseas clinical trials:
1) Differences in technical review requirements
Clinical trials conducted overseas may meet the technical review requirements of the country (region) where the trial is conducted, but may not fully meet the relevant review requirements in China.
2) Differences in subject population
Factors that may affect clinical trial data due to differences in test populations include:
(1) Intrinsic factors: Influencing factors based on human genetics or demographics, including race, age, gender, etc.
(2) External factors: refers to factors that are based on social environment, natural environment, and culture, including dietary habits, religious beliefs, exposed environment, smoking, drinking, disease incidence, rare or regional co-morbidities, obesity, treatment concepts, Socio-economic conditions, education, medical compliance, etc.
(3) Differences in clinical trial conditions
Differences in clinical trial conditions include: medical environment, medical facilities, researcher capabilities (learning curve), differences in diagnostic concepts or guidelines, etc.
How IVD reagents are exempted from clinical trials
Only the Class I IVD products, calibration IVD products and quality control IVD products could be exempted from the clinical trials.
How to reduce the clinical trial requirements for IVD reagents
Scope of application:
In the catalog of IVD reagents exempted from clinical trials
Requirements for the samples:
1. Select samples that cover the intended use and interference factors for evaluation research, and fully consider the selection of subject population, disease, etc. The samples should be able to fully evaluate the safety and effectiveness of the product for clinical use.
2. The sample size should be calculated using reasonable statistical methods and should meet the statistical requirements.
(1) The total sample size is not less than 40, and the test is performed in duplicate with the reagent to be evaluated and the comparison reagent / reference method. The sample outside the reference interval should be not less than 50%.
(2) The total sample size is not less than 100, and a single measurement is performed using the reagent to be evaluated and the comparison reagent / reference method.
At least 50 positive samples and 50 negative samples. Set acceptable standards for clinical evaluation performance indicators. If the research test results fail to meet the preset standards, the sample size should be appropriately expanded.
Note：In addition to the above methods, it is also possible to reduce clinical trial requirements through clinical trial protocol design, such as small sample clinical trials.