TX Q&A

Artificial vertebral body products are used for vertebral replacement to provide immediate stability. Products with different materials for the parts that perform the main functions (e.g., the material replacing the vertebra, including the material grade) should be divided into different registration units. According to the commonly used materials for artificial vertebral body products, artificial vertebral bodies made of materials like polyetheretherketone (PEEK), TC20 titanium alloy, and TC4 titanium alloy are divided into different registration units. If the materials of the product components are different, but the products are used as a whole assembly or combination, they can be declared under the same registration unit. Standardized artificial vertebral bodies and customized artificial vertebral bodies belong to different registration units.

The "Guidelines for Registration Application Materials of Influenza Virus Nucleic Acid/Antigen Detection Reagents" have been published for many years, requiring inclusivity or cross-reactivity studies of influenza virus subtypes that have circulated in China during product clinical trials, as per the guidelines. In recent years, there have been few reports of human infections with the highly pathogenic avian influenza H5N1 subtype in China, making it difficult for applicants to obtain clinical cases infected with this virus subtype during the clinical trial process of related products. Given this situation, provided that the analytical performance evaluation has sufficiently verified the detection capability for this virus subtype, it is not necessary to separately collect clinical cases infected with this virus subtype for inclusivity or cross-reactivity studies during the clinical trial process.

Animal testing primarily provides evidence to support the finalization of product design and serves as a basis for determining whether a medical device can enter the clinical research phase, thereby protecting clinical subjects. If the product employs a new mechanism of action, working principle, structural design, application method (e.g., surgical operation), or improves certain aspects of performance, the applicant should assess the risks related to the product's innovation points and verify and/or confirm the effectiveness of risk control measures, deciding whether to conduct animal testing based on the principles of risk management. If the proposed CO2 laser therapy device adopts a new structural design, improves performance, or introduces new functionalities (such as dot matrix scanning) for new clinical uses, and if bench performance testing is insufficient to determine its basic safety, it is recommended to conduct animal testing before clinical trials. Animal testing does not necessarily require a control group.

Companies should conduct microbial ingress evaluations on infusion needleless connectors, referring to YY/T0923 and combining it with Appendix C of YY0581.2 to carry out microbial ingress tests. During the testing process, the disinfection methods claimed by the company for clinical use, the number of uses determined by simulating the maximum number of clinical uses or the longest days of use, etc., should be adopted. At the same time, companies should include microbial ingress evaluation in the performance indicators of the product technical requirements and submit a test report issued by a testing organization qualified to undertake the inspection. In addition, companies should specify the product's disinfection method and number of uses in the product instructions, which should be consistent with the corresponding content in the microbial ingress evaluation tests in the technical requirements.

For large imaging equipment (such as CT, MR, PET/CT, etc.) that provides a third-party physiological gating interface, such as a respiratory gating interface or an ECG gating interface, it should be clearly stated in the summary documents the requirements for third-party gating devices that can be used in conjunction, such as interface type (including connection methods, data protocols, etc.), compliance standards, etc. If it is a proprietary interface, the manufacturer and product model of compatible devices should also be specified. Research documents should provide verification and confirmation materials for tests conducted with third-party devices. The product technical requirements should specify the interface type (including connection methods, data protocols, etc.) and compliance standards (if applicable), and technical indicators related to gating should be tested.

For large imaging equipment (such as CT, MR, PET/CT, etc.) that provides a third-party physiological gating interface, such as a respiratory gating interface or an ECG gating interface, it should be clearly stated in the summary documents the requirements for third-party gating devices that can be used in conjunction, such as interface type (including connection methods, data protocols, etc.), compliance standards, etc. If it is a proprietary interface, the manufacturer and product model of compatible devices should also be specified. Research documents should provide verification and confirmation materials for tests conducted with third-party devices. The product technical requirements should specify the interface type (including connection methods, data protocols, etc.) and compliance standards (if applicable), and technical indicators related to gating should be tested.

The inspection indicators for a product's oxygen permeability mainly include the oxygen permeability coefficient and the amount of oxygen transmitted. The oxygen permeability coefficient is related to the lens material formula and not to the lens thickness. However, the amount of oxygen transmitted is directly related to the lens thickness. When changing the product's center thickness, it is necessary to consider performing a risk analysis on how changes in lens thickness affect the amount of oxygen transmitted and, if necessary, provide corresponding validation data. Attention should be paid to whether the nominal value of the amount of oxygen transmitted needs to be modified. If a modification is indeed necessary, the corresponding test reports should be submitted as supporting documents, along with the rationale for setting the oxygen transmission indicators.

Generally, the selection of a typical model for testing within the same registration unit of medical endoscopes should consider the following factors: if there is a difference in the direction of view, the maximum value should be chosen; if there is a difference in the field of view, both the maximum and minimum values should be chosen; for endoscopes with different inner diameters, outer diameters, and working lengths, the one with the smallest diameter and the highest aspect ratio (length/diameter) should be chosen. For products with a working channel, the diameter should be the outer diameter of the insertion part minus the inner diameter of the working channel; for optical performance indicators like angular resolution, the model with the highest requirements should be chosen.

The appendix of the technical requirements for in vitro diagnostic reagent products requires the source of the main raw materials to be marked. If purchased externally, the supplier should be specified. Here, the supplier should be the producer of the raw materials, not a distributor or agent. Accordingly, a change in the suppliers of the main raw materials in the case of registration changes refers to a situation where the producer of the raw materials has changed.

Dental composite resin materials typically refer to three-dimensional compounds composed of at least two different chemical substances with a clear interface separation, mainly including the resin matrix, surface-treated inorganic or organic fillers, and initiator systems, as well as containing other components like inhibitors and pigments, used for direct filling restorations or base linings for dental defects. Products with different curing mechanisms (such as light curing, chemical curing) should be classified into different registration units; products with different main chemical components in the resin matrix should be classified into different registration units; products whose key performance indicators (such as wear resistance, polymerization shrinkage) and expected clinical use or purpose change due to changes in the chemical components of the reaction system should be classified into different registration units; products with different clinical application techniques should be classified into different registration units. Products that only differ in color can be declared as a single registration unit.