TX Q&A

Biological test reports from foreign labs must be accompanied by quality assurance documents from the lab indicating compliance with GLP lab requirements. If they meet relevant technical requirements (such as GB/T 16886/ISO 10993 series standards), they can be submitted as biological test data to support medical device biological evaluations.

Consumables for assisted reproductive technology (excluding liquids for assisted reproductive technology) target gametes, zygotes, and embryos at different developmental stages. In addition to routine biological evaluation, in vitro mouse embryo testing should also be conducted in accordance with YY/T1434-2016.

The collection, analysis, and evaluation of clinical data of the same type of medical device play different roles depending on the design characteristics, key technologies, scope of application, and level of risk of the declared product. This includes confirming whether the safety and effectiveness of the same type of medical device have been clinically recognized, whether the risk-benefit ratio is acceptable, identifying the clinical usage risks of the same type of medical device to provide information for the risk-benefit analysis of the declared product, confirming residual risks through clinical data compared to non-clinical studies, and providing clinical data for the evaluation of test results for some non-clinical studies (such as bench tests). In addition to clinical literature data, clinical experience data, and clinical trial data, clinical data of the same type of product also include completed clinical research datasets, adverse event datasets, and corrective action datasets related to clinical risks. Adverse event datasets can be obtained through post-market complaints and adverse event disclosures by regulatory agencies. Furthermore, the applicant needs to confirm whether the selected same type of product is one with a high clinical focus among similar products, whose safety and effectiveness have been recognized, and whether the literature search strategy is appropriate and can ensure comprehensive retrieval.

Yes, but it is important to collect data from before and after the product was listed as a Class II product, and to analyze and summarize it reasonably. The main focus should be on whether the declared product can achieve the expected performance under normal conditions of use; whether the risks of the product are acceptable compared to the expected benefits; and whether there is sufficient evidence to support the clinical performance and safety of the product.

In the "Technical Guidance Principles for Medical Device Clinical Evaluation", it is mentioned that "each item compared with each same type of medical device should include but not be limited to the items listed in Appendix 2" and also states that "if there are items that are not applicable, the reasons for their inapplicability should be explained." Appendix 2 lists items including basic principles, safety standards, compliance with national standards, industry standards, and scope of application. When conducting comparisons, the applicant should consider the design characteristics, key technologies, scope of application, and level of risk of the product, select comparison items, and provide reasons. For example, when comparing ultrasound therapy devices, the focus should be on the device's structural composition, basic principles, main performance indicators, key components (mainly the probe or treatment head), intended use, etc. For production processes and methods of use, since the impact of production processes on the safety and effectiveness of the product can be evaluated through comparisons with other items, and the methods of use are generally similar for similar products, a comparison may not be necessary.

According to the "Technical Guidance Principles for Medical Device Clinical Evaluation" (CFDA Notice No. 14 of 2015), when analyzing and evaluating clinical data of the same type of medical device, it is explicitly stated that the data should be legally obtained. Based on the requirement that the data should be legally obtained, if conducting clinical evaluation according to Article 6 of the guidelines and using production processes, clinical data, and other information of the same type of medical device, the applicant should submit an authorization letter for the use of production processes, clinical data, and other information of the same type of medical device. The "Interpretation of Regulations on Medical Device Registration Management Five" further clarifies the authorization requirements for clinical evaluation data of medical devices, particularly for non-public data of the same type of medical device, to ensure the legality of the data source; for publicly published data such as literature, data, and information, no authorization is required. Therefore, when conducting clinical evaluations through comparisons with the same type of medical device and selecting products from other registrants as the same type of medical device, if the data comes from public sources, experimental measurements, industry consensus, etc., there may be no requirement to provide a data authorization letter.

For peripheral vascular stent products, the main recommended endpoint for current clinical trials is generally the target vessel patency rate at 12 months.

Suture anchor nails are used for fixation between bone and soft tissue, consisting of sutures and anchor nails. If the composition materials of the anchor nails (including material specifications) are different, they should be divided into different registration units. Similarly, if the composition materials of the sutures used in conjunction are different, they should also be divided into different registration units. If the declared product is composed of multiple sutures or if one suture is made from multiple materials but is used as a whole assembly or in combination, it can be declared under the same registration unit.

During the registration application for in vitro diagnostic reagents, clinical trials must comply with the ethical guidelines of the Helsinki Declaration and must obtain approval from the ethics committee of the clinical trial institution. In this section of the application materials, the review opinions of the ethics committee and a sample of the informed consent form for subjects should be submitted. The written approval from the ethics committee to conduct clinical trials should be submitted in its original form, stamped by the ethics committee, and should clearly state the version number and date of the protocol. Attention should be paid to ensuring the consistency of product information and clinical trial information with actual clinical conditions. If there are any protocol modifications during the trial, they should be approved by the ethics committee, and the committee's opinions on the protocol modifications should be submitted. All institutions conducting clinical trials should submit the review opinions of the ethics committee. If special medical institutions (such as disease control centers, etc.) do not have an ethics committee, the institution should provide relevant explanations and opinions on ethical aspects. If, after review and approval by the ethics committee, the clinical trial is exempt from obtaining informed consent from subjects, this exemption should be clearly stated in the written opinion of the ethics committee to avoid situations where the actual trial is exempt from informed consent, while the informed consent form is still mentioned in the ethics committee's written opinion.

Yes, they can. The "Guidelines for the Design of Clinical Trials of Medical Devices" clearly state that these guidelines apply to medical devices with established product composition, design, and performance, including therapeutic and diagnostic products, but not in vitro diagnostic reagents. Therefore, when calculating sample size in the design of clinical trials of clinical testing instruments, the relevant requirements of these guidelines can be referenced.