TX Q&A

According to the "Guidelines for the Technical Review of Cybersecurity Registration for Medical Devices," registration applicants should clearly specify the requirements for data interfaces and user access control in the product's technical performance indicators. For products approved before the issuance of these guidelines that do not reflect this indicator, if the registration change application involves cybersecurity content, the cybersecurity performance indicators should be supplemented in the product technical requirements. A qualified inspection agency should then conduct a registration inspection or commissioned inspection on the supplementary items. A cybersecurity description document should also be submitted simultaneously with the application materials.

According to the YY 0053 regulation, the clearance rate test for dialyzer products should cover the range of blood and dialysate flow rates specified by the manufacturer. The test typically selects the lowest and highest points of the dialysate flow rate, which correspond to the lowest blood flow rate set by the manufacturer, and then increases the blood flow rate by 100ml/min until it reaches the maximum blood flow rate specified by the manufacturer.

If the manufacturer claims that soft hydrophilic contact lenses are ionic or non-ionic, the determination should be made based on the definitions of ionic and non-ionic types given in GB/T 11417.1-2012. First, it is necessary to clarify the nature of each monomer in the product formula, such as whether they are ionic or non-ionic, etc. Secondly, calculate the content of ionic monomers (expressed in mole fraction). Finally, make a conclusion based on the relevant requirements of GB/T 11417.1-2012, and clearly state in the appendix of the product technical requirements whether the soft hydrophilic contact lenses are ionic or non-ionic.

During the clinical trial process of in vitro diagnostic reagents, to control trial bias, the consistency statistical analysis between the assay reagent and the comparative reagent should use the test results before sample unblinding. Including the retest results of inconsistent samples or third-party confirmation results in the statistical analysis after the clinical trial unblinding would introduce bias. Therefore, it is not recommended to include these results in the statistical analysis. However, the retest results of the assay reagent and the third-party review reagent test results can be combined with the clinical diagnosis information of the corresponding case to further analyze the reasons for the inconsistency between the test results of the assay reagent and the comparative reagent.

Currently, there are no recognized standards or methods for the limit values and testing of residual glutaraldehyde. According to the provision 4.3b) in GB/T 16886.1-2011, the overall biological evaluation should consider the expected additives, process contaminants, and residuals. If the medical device samples for biological testing have been disinfected and sterilized with glutaraldehyde according to the manufacturer's specified method and meet the requirements for biocompatibility, then their residual toxicity is considered acceptable.

Pre-library construction reagents generally include components related to pre-library preparation such as end repair, adapter ligation, and amplification, which are used for the general processing of gene sequencing libraries. Subsequent steps require using other components in the kit for the library's specific identification or enrichment. Considering that the pre-library preparation step is a critical step in detection based on second-generation sequencing technology, whether the quality of pre-library construction reagents is stable directly affects the accuracy of the detection results. If separated, it would not be conducive to the applicant's stable control over product performance. Therefore, applicants should include pre-library construction reagents in the composition of the kit for registration. It is worth noting that in the current medical device classification catalog, there are already classified (pre) library construction reagents, all managed as class III devices. Therefore, pre-library construction reagents cannot be separately divided for registration.

The disposable rotary cutting needle is an active accessory. According to the "Guiding Principles for the Division of Medical Device Registration Units," active medical device accessories used in connection with a main unit should, in principle, be declared as the same registration unit.

Artificial intervertebral disc prostheses are used for disc replacement and generally consist of upper and lower endplates and a middle nucleus prosthesis. According to the applicable site, they are divided into artificial cervical discs and artificial lumbar discs. If the main functional components of the artificial intervertebral disc prostheses (including material grades) or the coating materials differ, they should be divided into different registration units. Products with different structural design types, such as motion-preserving types, motion-restricting types, and fixed-structure types, should be divided into different registration units. Artificial intervertebral disc prostheses with different articular surface material combinations should be divided into different registration units. For example, based on the commonly used metal materials for the upper and lower endplates of artificial intervertebral discs, they can be divided into registration units such as forged cobalt-chromium-molybdenum alloy, TC20 titanium alloy, TC4 titanium alloy, etc. If the materials of the product components differ, but the products are used as a whole assembly or combination, they can be declared as the same registration unit.

In addition to complying with the "Guiding Principles for the Division of Medical Device Registration Units" in the "Notice on the Guiding Principles for the Division of Registration Units for Non-Active Medical Devices (No. 187 of 2017)", the following situations should also be met: 1. If the final ion concentration of the dialysis fluid made from the concentrate differs, it is recommended to distinguish different registration units. 2. If the state of the concentrate provided is different, such as liquid-liquid, powder-powder, it is recommended to distinguish different registration units.

Given that pre-filled syringes serve not only as the inner packaging containers for the devices but also have the function of injection, it is essential to consider performance indicators and testing methods related to them in the product technical specifications from the perspective of the final product, regardless of whether they have obtained the drug packaging material or medical device registration certificate. These include pushing force, syringe appearance (which can be combined with product appearance), scale, Luer lock (for non-Luer locks, it is required that the syringe and injection needle fit without leakage), effective capacity (or filling volume), barrel tightness (no gel leakage at the piston or when tested with water), and the fit between the piston and the outer cover (the core rod does not move due to gravity when held vertically), etc. Specific performance indicators and testing methods can refer to GB 15810 or relevant national/industry standards.