The requirements for the clinical evaluation of in vitro diagnostic reagents in the In Vitro Diagnostic Reagent Registration and Management Measures are as follows:
Article 28: The clinical evaluation of in vitro diagnostic reagents refers to the applicant or filing person passing the clinical literature. , clinical experience data, clinical trials and other information to confirm whether the product meets the usage requirements or intended use.
Article 29 Clinical evaluation materials refer to the documents formed by the clinical evaluation conducted by the applicant or the filing party.
Clinical trials of in vitro diagnostic reagents (including comparative research tests with already marketed products) collected and compiled by the Medical Education Network refer to the systematic review of the clinical performance of in vitro diagnostic reagents in the corresponding clinical environment. Research.
For in vitro diagnostic reagents that do not require clinical trials, the applicant or filing party shall evaluate the in vitro diagnostic reagents through non-clinical tests such as evaluation of clinical samples covering the intended use and interference factors, comprehensive literature materials, etc. Clinical performance was evaluated. The applicant or filing party should ensure that the clinical samples used for evaluation are traceable.
Article 30: Registration of Class I in vitro diagnostic reagents does not require clinical trials. To apply for registration of Class II and Class III in vitro diagnostic reagents, clinical trials must be conducted.
If one of the following circumstances occurs, you may be exempted from clinical trials:
(1) The reaction principle is clear, the design is finalized, the production process is mature, and the same type of in vitro diagnostic reagent is already on the market It has been clinically used for many years without serious adverse event records, does not change its regular use, and the applicant can provide equivalence evaluation data with already marketed products;
(2) Through clinical analysis covering the intended use and interference factors The evaluation of samples can prove that the in vitro diagnostic reagent is safe and effective.
The catalog of in vitro diagnostic reagents exempted from clinical trials shall be formulated, adjusted and published by the State Food and Drug Administration.
Article 31: When the same registration application includes different packaging specifications, only samples of one packaging specification can be used for clinical evaluation.
Article 32: Applicants for Category III products should select no less than 3 (including 3) companies, and applicants for Category II products should select no less than 2 (including 2 companies). ) Qualified clinical trial institutions shall conduct clinical trials in accordance with relevant regulations. The production of clinical trial samples should comply with the relevant requirements of the medical device quality management system.
Article 33 The applicant shall sign a clinical trial contract with the clinical trial institution, formulate and improve the clinical trial plan with reference to relevant technical guidelines, provide samples for clinical trials free of charge, and bear the clinical trial costs.
Article 34 The number of clinical trial cases shall be determined based on the purpose of the clinical trial, statistical requirements, and with reference to relevant technical guidelines. Technical guidelines for clinical trials will be released separately.
For in vitro diagnostic reagents that are urgently needed for rare diseases and in response to public health emergencies, if it is required to reduce the number of clinical trial cases or waive clinical trials, the applicant shall submit the registration application materials at the same time , submit an application for exemption from clinical trials and explain the reasons in detail. The technical review agency of the food and drug administration department will conduct a comprehensive technical review of the registration application materials before making a determination. If additional clinical trials are needed, the applicant will be notified by supplementing the information.
Article 35 When applying for registration of imported in vitro diagnostic reagents, overseas clinical evaluation data must be provided. Applicants should follow the requirements of clinical evaluation, while taking into account factors such as the epidemiological background of different countries or regions, the characteristics of different diseases, the positive judgment values ??or reference intervals applicable to different species of people, and carry out targeted evaluation in China. clinical evaluation.
Article 36 After completing clinical trials, clinical trial institutions shall issue clinical trial reports respectively. The applicant or the clinical trial leading unit shall summarize the clinical trial results and complete a clinical trial summary report according to relevant technical guidelines.
Article 37: In clinical trials of in vitro diagnostic reagents for personal use by consumers, the evaluation of the cognitive ability of the product instructions by consumers without medical background should be included.
Article 38 If the applicant discovers that the clinical trial institution has violated relevant regulations or failed to implement the clinical trial plan, it shall urge it to make corrections; if the circumstances are serious, it may request the suspension or termination of the clinical trial and report to the clinical trial institution Report from the food and drug administration department of the province, autonomous region, or municipality directly under the Central Government where the institution is located and the State Food and Drug Administration.