TX Q&A

The "Product Performance Indicators" section of the instructions for in vitro diagnostic reagents should include all the analytical performance assessments and clinical trial results of the product. For in vitro diagnostic reagents exempt from clinical trials, the results of their clinical evaluations must be stated.

The catalog specifies that exemptions do not include products with new materials, new mechanisms of action, or new functions. Here, "new" refers to materials, mechanisms of action, and functions that have not been used in similar infusion devices already marketed domestically. Regarding new materials: For instance, if the TOTM plasticizer used in PVC materials for infusion tubing has already been used in similar marketed products, an infusion device made with PVC materials containing TOTM plasticizer is not considered to use new materials and can be exempt from clinical evaluation. Regarding new mechanisms of action: If an infusion device uses a float-type or membrane-type stop fluid component, and the same component has been used in similar marketed products, this mechanism of action is not considered new. Thus, the product can be exempt from clinical evaluation during the registration process. Regarding new functions: For example, if an infusion needle offers anti-needlestick functionality, and this function has already been used in similar marketed products, it is not considered a new function. Therefore, the product can be exempt from clinical evaluation during the registration process.

When conducting clinical trial registrations and applications for reversed typing red blood cell reagents and microcolumn gel card products, it is essential to consider the compatibility of the products. It is also important to ensure that both the in vitro diagnostic reagents and the comparative methods used in the clinical trials are performed with the corresponding reversed typing red blood cell reagents and microcolumn gel cards. Generally, the instructions for reversed typing red blood cells do not specify the microcolumn gel cards to be used in conjunction. However, the instructions for the microcolumn gel cards will specify the compatible reversed typing red blood cells. Special attention should be paid to the microcolumn gel card product instructions regarding the specified reversed typing red blood cells.

When selecting the worst-case samples for the mechanical performance of intervertebral fusion devices, it is important to consider factors such as the size of the graft area, the size of the side holes, the angle of inclination, length, width, and height of different models and specifications of the fusion devices. These factors can affect the mechanical performance of the product. Additionally, since mechanical performance indicators vary (such as compression, compressive shear, torsion, etc.), the model and specifications of the worst-case samples may also differ. By integrating the methods and loading modes of the dynamic and static mechanical performance tests for cervical and thoracolumbar intervertebral fusion devices, a comprehensive consideration should be given to the selection of the worst-case samples for both cervical and thoracolumbar intervertebral fusion devices.

It is recommended that ultrasound imaging equipment used for positioning not be considered part of the structural composition of HIFU products, but rather as accompanying equipment. If ultrasound imaging equipment is to be included as part of the product structure, documentation must be provided that meets all the requirements for imaging ultrasound equipment, including relevant standards and inspections, biocompatibility, sterilization, and acoustic output safety. If it is not part of the product composition and is used in conjunction with the product, it is advised to specify the specifications, model number, and software version of the accompanying product. Additionally, it should be demonstrated that it meets the requirements of section 5.4 related to positioning devices in YY 0592-2016.

Considering the lighting and power supply methods of dental mobile phones and connectors (if any), there are three types: with lighting devices, light-guiding, and without lighting. Structures with lighting devices include a light source; light-guiding structures do not contain a light source, only a bundle of optical fibers; structures without lighting neither contain a light source nor a light-guiding device. Structures with lighting devices should reference the GB 9706.1 and YY 0505 standards, while light-guiding and non-lighting types do not need to reference the GB 9706.1 and YY 0505 standards.

The raw materials of absorbable products can be absorbed by the human body, which may pose safety risks regarding their metabolism inside the body. However, for most established materials such as sodium hyaluronate, animal collagen, chitosan, starch, and polylactic acid, there is abundant research literature available, and their metabolic pathways are relatively fixed. The effects of dosage, cross-linking degree, and individual differences on metabolic pathways are minor and generally do not result in significant changes. Therefore, for products made from the aforementioned established materials, it is not necessary in principle to provide in vivo metabolic study data for the product. Existing literature can be provided as support, or the product's safety can be verified through biocompatibility evaluations. If a product uses a new absorbable material and lacks relevant research data on its metabolism in the body, an in vivo metabolism study for the product is required.

The answer is that, in principle, material properties are not included as performance indicators in the technical requirements of products. This includes, but is not limited to, the chemical composition, microstructure, and internal quality of metal materials; infrared spectra of polymer materials; and the chemical composition, impurity element content, thermal conductivity, and crystalline phase content of ceramic materials. For material characterization information that is truly related to product safety, it can be specified in an appendix to the technical requirements.

According to Article 16 of the "Regulations on the Management of Instructions for Use and Labels of Medical Devices," changes to the content of the instructions for use that do not fall within the scope of registration changes should be notified in writing to the medical device registration approval department, along with the submission of relevant documents such as a comparison explanation of the changes to the instructions for use. After receiving an application for a notification review of changes to the instructions for use, CMDE will review the technical content of the application based on the requirements for file establishment. During the review process, if it is found that the application content involves issues that require the registrant to provide supporting documentation, a notice of acceptance for correction will be issued, specifying the specific problems with the application and the documentation that the registrant needs to submit. If, upon review, it is determined that the changes do not fall within the scope of the notification for changes to the instructions for use, the notice of acceptance for correction will clearly specify the non-conforming content and reasons, as well as the process for handling the changes through registration modification.

The risk varies depending on the animal source, production process, and application scope of the products. For some common viral inactivation processes, such as organic substances, radiation, and strong acids, the procedures and methods are relatively mature and there is abundant reference literature available, making it unnecessary to perform laboratory validation for each one. For animal-derived products, especially those with well-established raw material applications, the effectiveness of viral inactivation can be evaluated using literature or historical data.