TX Q&A

According to the "Technical Review Guidelines for the Registration of 3D Printed Artificial Vertebral Body Products" and the "Guidelines for the Preparation of Technical Requirements for Medical Device Products," additively manufactured artificial vertebral body products usually need to include performance indicators such as microstructure, surface quality, internal defects, mechanical properties (like hardness and stiffness), and sterility (if applicable). Mechanical performance indicators such as static torsion, compression, shear, subsidence, and extrusion should be provided as research data.

Absorbable intramedullary fixation implants designed for the fixation of diaphyseal fractures in the long bones of the limbs, which feature new designs, materials, or mechanisms compared to existing products on the domestic or international market, require clinical trial approval before conducting clinical trials.

When conducting mechanical testing research on metallic bone plate products, the test samples selected need to represent the worst-case scenario of all the products being declared. The worst-case scenario can be determined using various methods; it is not mandatory to use the finite element analysis method for selection.

Yes, it is acceptable. The applicant for the citric acid disinfectant solution should incorporate the production quality control of this chemical raw material into their own production management system.

When a registrant applies for a change in the performance indicators of a product, the change declaration must clearly state the reasons and purposes for the changes in the product's performance indicators, provide a detailed description of the specific changes to the product, and analyze the impact of those changes on the product's performance. If the registrant claims that the product itself has not changed, they must explain in detail from the perspective of product design and development why the performance indicators have changed even though the product has not. Supporting documentation must also be provided.

During EMC testing, some test items require the device to operate continuously for extended periods. If the attached accessories cannot complete the required continuous test duration, you may replace them with the same model and batch accessories to continue the test. It is essential to consider whether replacing the accessories during the test will affect the test results. It is recommended to take appropriate test intervals based on the expected lifespan of the accessories or to set up suitable test fixtures.

Continuous operating time considers whether the device can function normally under continuous operation without issues such as overheating or overloading, or the maximum operating duration that can be supported by the internal power source battery. If the product is designed for a preset work cycle of 30 minutes, and it can start the next work cycle immediately after the timer ends, without any restrictive description given by the applicant regarding treatment duration, cycle, or interval, the product is considered to be in continuous operating mode. It should meet the relevant electrical safety requirements for continuous operation, and the corresponding continuous operating time can be calculated by accumulating the maximum number of work cycles that the device can endure or support. It's important to note that in such scenarios, the applicant should not directly claim in the manual that "the product can continuously operate for XX time". Instead, they should explain the maximum single cycle duration, the tolerable work cycle, and the method of testing and calculating cumulative operating time. This helps prevent any misunderstanding by users that could lead to potential risks.

Yes, the interference of additives on sample analysis results should be considered. The currently used anticoagulant is heparin. Known interferences of heparin with results include dilution effects, sodium heparin causing elevated sodium ion results, lithium heparin binding to calcium ions resulting in lower calcium ion results, and effects on pH levels. For products claimed to be suitable for testing corresponding items in blood (such as pH, potassium, sodium, calcium, chloride, electrolytes, hemoglobin, hematocrit, glucose, and lactate), research data must be submitted to demonstrate that the product does not interfere with the testing of these blood components, or that any interference is within acceptable limits.

Degradation studies should include both in vitro and in vivo degradation. In vitro degradation can refer to YY/T 1806.1, YY/T 0473, YY/T 0474, and YY/T 0509 for real-time or accelerated degradation tests. The basis and rationality for setting the test time points must be clarified. For in vivo degradation, the test period should be set according to the needs of safety and efficacy studies. Based on the evaluation of the product's degradation time from in vitro degradation tests, an observation period should be determined. This observation period should include at least three time points: no or minimal degradation, during the degradation process, and when the tissue response has stabilized or the product at the implantation site has almost completely disappeared.

Both remote maintenance and remote diagnosis functions involve remote communication. The remote maintenance function generally only involves the transmission of device data for routine maintenance and repair, while the remote diagnosis function involves the transmission of patient data and ultrasound images for remote viewing of ultrasound images or performing remote diagnosis. For these functions, you should provide network security research materials, clearly stating the detailed purposes and the types of data involved in the transmission. The product technical requirements should clearly specify the corresponding functional requirements, and inspection reports should be provided. Research materials should include validation data for the stability of data transmission. If remote diagnosis is involved, additional documentation should be provided to show that data delay and image quality meet clinical needs. It's important to note that if patient information and image data are routed through overseas servers, they must comply with relevant data export laws and regulations. Applicants should fully inform user institutions about the risks, responsibilities, related warnings, and compliance regarding data export, and both parties should jointly bear the responsibility for data export registration.