TX Q&A

Since children or newborns are very sensitive to X-rays, if the applicant claims that the device is suitable for the pediatric population, measures to reduce the radiation dose for children or newborns should be provided. Such measures might include automatic exposure control designed and calibrated for pediatric patients; low radiation dose protocols suitable for infants; special filtration; radiation incident doses lower than those for adults, exposure limit warnings; display and recording of patient dose information or dose indices along with other patient information such as age, height, and weight (manually entered or automatically calculated); and filters or grids that can be removed without tools, among others.

Since the existing registration certificate and its attachments have already specified the shelf life of soft contact lens products, changes should be made according to the change procedures of licensing items. It is recommended to refer to GB/T 11417.8-2012 "Ophthalmic optics - Contact lenses - Part 8: Determination of shelf life" for conducting shelf life studies. A complete real-time aging study report must be provided when applying.

Whether an in vitro diagnostic reagent product is related to the prevention and treatment of rare diseases should be determined based on documents such as the "Guidelines for the Registration Review of Medical Devices for the Prevention and Treatment of Rare Diseases" (No. 101 of 2018), the "Notice on the Publication of the First Batch of Rare Disease Catalog" (National Health Commission Medical [2018] No. 10), and the "Notice of the General Office of the National Health Commission on the Issuance of the Rare Disease Diagnosis and Treatment Guidelines (2019 Edition)" (National Health Office Medical Letter [2019] No. 198). If the clinical indications of the product being applied for are diseases listed in the first batch of the rare disease catalog, and according to the Rare Disease Diagnosis and Treatment Guidelines (2019 Edition), the diagnosis and treatment process for the disease requires the testing items corresponding to the product being applied for, then the product can be considered as related to the prevention and treatment of rare diseases. For new biomarkers developed for the testing items of the product being applied for, it is necessary to clarify the intended use of the product and its relationship with the diagnosis and treatment of the related rare diseases, in order to determine whether it belongs to products for the prevention and treatment of rare diseases. If necessary, communication and consultation with CMDE can be sought.

In the design and development process of suture anchor products, the performance indicators and their requirements for sutures should be established from the perspective of the product's clinical needs and intended use. This involves taking into account the product's application area and specific method of use, and comprehensively considering the quality control requirements for the suture's performance itself, to determine the performance indicators and requirements for the sutures in suture anchors. Suture anchors are typically used for the fixation of bone and soft tissue and are classified as Class III medical devices, unlike Class II non-absorbable surgical sutures. When referring to relevant national or industry standards during product design and development, the applicability of the standards should be carefully considered.

Changes to the plasticizers in the main raw materials of infusion products require initial registration.

For universal imaging guidance systems, it's necessary to select representative radiation therapy systems for compatibility verification and provide the verification test data. Explain why the chosen radiation therapy systems are considered representative. The overview documents should clearly specify the general requirements, types of interfaces, and other information for the radiation therapy systems that can be used in conjunction. Dedicated imaging guidance systems should undergo verification tests with the radiation therapy systems they will be used with and provide the verification test data. The overview documents should clearly state information about the radiation therapy systems being used, including the manufacturer, model, and registration certificate number (provide a copy of the registration certificate).

Clinical trials for in vitro diagnostic reagents typically involve comparative studies between the test in vitro diagnostic reagents and clinical reference standards and/or similar products that are already on the market, to evaluate the clinical performance of the test in vitro diagnostic reagents. This provides scientific and effective clinical evidence for the confirmation of the product's safety and efficacy. Here, "similar products already on the market" refers to similar products that have been approved for marketing domestically. For situations where there are no clinical reference standards available for comparison, or the existing clinical reference standards cannot fully evaluate the product's clinical performance, the clinical trial design should, under the premise of confirming the clinical significance of the analyte, also choose appropriate laboratory methods based on current clinical practice and theoretical foundations for testing performance evaluation, such as comparative trials with clinically recognized, standardized laboratory reference methods. If there are similar products already approved for marketing abroad, with the same intended use as the test in vitro diagnostic reagents, and if the product has undergone thorough performance validation and confirmation, can achieve good quality control during laboratory testing, and is widely recognized clinically for the detection of relevant biomarkers, then such products can also be used as laboratory testing methods for comparison.

The quality control materials for in vitro diagnostic reagents are used for quality control of the testing system. Applicants should validate the expected results (target values and target value ranges) of the quality control materials for the declared reagents and clearly specify the validated quality control materials in the reagent instructions. Terms like "unverified third-party quality control materials" or "other commercial quality control materials" should not appear in the product instructions.

If processing aids expected to potentially impact human safety are added during the device manufacturing process and cannot be verified to be completely removed during production, or when processing aids could pose significant hazards to human health and need to be strictly controlled, considering the close relationship with the final product's safety and quality control, it is necessary to establish control items such as residual limits for processing aids in the product technical requirements. At the same time, corresponding research materials on the control of all processing aids involved in the product production process should be submitted.

Root canal preparation auxiliary materials are used during root canal treatment surgery to clean and remove residues such as root canal walls and pulp tissue, or to assist in root canal preparation such as decalcification of root canal walls, or to treat root canals before root canal filling, or to dissolve root canal filling materials that have been filled in the root canal. Products with different intended uses should be divided into different registration units; products with different main components should be divided into different registration units; products with different mechanisms of action should be divided into different registration units.