FAQ

The technical guide describes the layout format including the font size, such as the font size is not less than four characters, the form text is not less than five characters, etc., which is only as a recommendation. The administrative counterpart should ensure that the electronic information submitted is clear and readable. If the format requirements for some materials are specified in the relevant guidelines, the corresponding requirements shall be complied with in the preparation of such materials.

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The aim of the clinical trial approval for class HI of high- risk medical device is to make a decision on whether to agree to conduct a clinical trial based on the application. The purpose is to protect the rights and interests of the subjects. The review focuses on preclinical research, clinical benefit and risk analysis of the product. The design of clinical schemes may affect the risks and benefits of clinical trials to subjects. Therefore, clinical trial plans are one of the review contents of clinical trial approval applications. However, the clinical trial approval process does not finalize the clinical trial plan submitted by the administrative counterpart. The administrative counterpart can refer to the communication with the review and approval personnel during the clinical device approval and registration process of the medical device, and modify and improve the clinical trial plan in accordance with the requirements of the GCP. The technical review agency will give a comprehensive evaluation of the safety and effectiveness of the product in the subsequent review and approval process.

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The page number of a single PDF file should have the correct and unique identification, to ensure that relevant information can be located through the page number. Each PDF file should be paged. The page number is recommended to reflect the directory number information where it is located. It should be clear and legible, and it is recommended to be in the middle of the bottom of the file. PDF files created after scanning can be paged by marking page numbers on paper.

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When conducting parallel controlled clinical trials, if a similar product already on the market cannot be used as a control product for reasonable reasons, product design characteristics, preclinical trial research results, risk and benefit analysis, clinical trial objectives, clinical trial evaluation indicators, and follow-up time may be considered in a comprehensive manner to select similar products that have been recognized for their efficacy and safety, the same scope of application as test equipment, and similar clinical evaluation indicators with test equipment as control products.

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Yes, the scope of the “Guidelines for Design of Clinical Trials of Medical Devices” is clearly state that this guideline applies to medical devices that have been finalized in product composition, design, and performance, including therapeutic products, diagnostic products, excluding in vitro diagnostic reagents (IVDs). Therefore, diagnostic devices can refer to the relevant requirements in this guideline when calculating the sample size for clinical trial design.

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The typical model(s) can be selected to conduct clinical trials. For other models without clinical trials, the identities and differences between other models and typical models should be detailed, and the evidence of clinical safety and effectiveness of the selected typical model products can be extrapolated to all models of products in question.

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Data from Chinese subjects is not compulsory when considering if the overseas clinical trial data of a medical device is acceptable. But the administrative counterpart should confirm that the population data studied can be extrapolated to the Chinese population. According to the “Guidelines for the Acceptance of Data from Overseas Clinical Trials of Medical Devices", the factors that may affect the results of clinical trials are not limited to ethnic differences. The factors of differences in the population and the conditions of clinical trials need to be comprehensively considered based on product characteristics. Although it is already known that such factors exist objectively and may have some influence on the clinical trial, the influence degree of such factors shall be judged in combination with the characteristics of the medical device under application and the purpose of the clinical trial. When it is determined that such factors have no actual clinically significant influence on the clinical trial data of most medical devices according to the development status, the experience in clinical application as well as the cognition of related diseases and diagnosis and treatment methods, it is not required to prove them one by one. When it is determined that or it is hard to determine whether some factors have clinically significant influence on the clinical trial data, the applicant shall explain the methods taken to reduce or eliminate the influence of each difference. For

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Medical devices listed in the “The Catalog of Class III Medical Devices that Needs Approval for Clinical Trial Conduction" also can submit overseas clinical trial data in accordance with the requirements in “Guidelines for the Acceptance of Data from Overseas Clinical Trials of Medical Devices". If the overseas clinical trial data is scientific, complete, sufficient and conforms to the requirements of Chinese regulatory based on ethical principles, legal principles, and scientific principles, no more clinical trials will require to conduct in China.

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There maybe differences for requirements of medical device clinical trial data in different countries. For example, for the design of a clinical trial, the requirement in some countries is that the clinical trial can reach the conclusion that the performance of a medical device achieves one observation endpoint. But the requirement for registration application in our country is that the effectiveness can only be verified until the performance of a medical device achieves multiple observation endpoints and there is appropriate evidence supporting the safety of the medical device. Therefore, the overseas clinical trial data may not fully meet the relevant review requirements in China. If the “guidelines for technical review of a specific medical device” issued by NMPA specified relevant requirements for the clinical trial of the medical device, such requirements shall be considered for the overseas clinical trial of the medical device. In case of any inconsistency, sufficient and reasonable grounds and basis shall be provided.

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The “Guidelines for the Clinical Evaluation of Medical Devices” mentions that "the items to be compared with each comparable medical device shall include but not be limited to the items listed in Appendix 2." It’s also mentioned that “the reasons need to be state clearly if not applicable”. Appendix 2 lists items including basic principles, safety standards, national/industry standards, and intended use. The design characteristics of the products, key technologies, intended use, and extent of the risks need to be fully considered, and choose applicable items and explain its reasons when administrative counterpart conducting comparation. For example, an ultrasonic physiotherapy equipment should take the items including device structures, basic principles, main performance indicators, key components (mainly refers to probes or treatment heads), intended use, etc., into consideration. For the items such as manufacturing technique, use methods, etc., the impact of manufacturing technique on the safety and effectiveness of the product can be evaluated by comparison with other items. The use methods are basically same between similar products, so comparison of these two items is not required.

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If the applicant can prove that the different individual test items do not interact with each other in the joint detection reagent and the intended use does not exceed the scope of the exemption catalogue, it can be considered the multi-analyte joint detection reagent is just a simple joint of several exempted reagents, and the performance of each test item can be evaluated separately in accordance with the clinical evaluation requirements as the product of the Catalogue. It is worth noting that the applicant should confirm that these test items have a clear significance of joint testing and the additional risks produced by the combination should be evaluated. At the same time, if it has a new clinical significance, the multi-analyte joint detection reagent should not be considered a product that complies with the Catalogue.

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