Determining the shelf life of in vitro diagnostic reagents
The shelf life of in vitro diagnostic reagent products should be determined based on real-time stability study data. Real-time stability study experiments should be completed before registration application, and the product's shelf life should be determined based on the test results. Real-time stability studies should include data from at least three batches of samples stored under actual storage conditions until the end of the product's shelf life. At the same time, adverse conditions during storage, transportation, and use of the product should be thoroughly considered, and corresponding stability studies should be conducted. If real-time stability studies are ongoing at the time of registration application, the shelf life can be determined based on completed experiments during the application, and after completing the relevant stability studies later, the shelf life can be extended through a change application.
How should the registration units for rib plates be divided?
Rib plates are used for internal fixation of rib fractures or deformity correction. Rib plates and limb fixation plates are classified as different registration units. If the materials used in the products are different (including material grades), they should be categorized into separate registration units. Based on the commonly used metal materials for rib plates, they can be divided into registration units such as TA3 pure titanium, Ti6Al7Nb titanium alloy, nickel-titanium alloy, etc.
When registering in China, are biocompatibility test reports issued by foreign labs recognized?
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.
Do consumables for assisted reproductive technology (excluding liquids for assisted reproductive technology) need to undergo mouse embryo testing after biological evaluation according to GB16886.1?
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.
When conducting clinical evaluation using clinical data of the same type of medical device, what should be done if clinical literature of the same type of medical device cannot be found?
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.
If a product moves from Class II to Class III, can the product after the category adjustment use its own clinical data as clinical data of the same type of product for clinical evaluation?
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.
Regarding the determination of the same type of medical device in the "Technical Guidance Principles for Medical Device Clinical Evaluation", it presents sixteen comparison items. Do you need to compare each item individually?
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.
When submitting clinical ethics documents in the registration application for in vitro diagnostic reagents, what should be noted?
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.
How should the registration units of suture anchor nail products be divided?
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.
When conducting clinical trials for peripheral vascular stent products, what are the main endpoint suggestions?
For peripheral vascular stent products, the main recommended endpoint for current clinical trials is generally the target vessel patency rate at 12 months.