TX Q&A

According to the principle that "within the same registration unit, the tested product should be a typical product that can represent the safety and effectiveness of other products within this registration unit", the typical product for registration testing should cover all product characteristics of the registration unit. For example, if there are suture needles with different needle types and different grades of stainless steel in the same registration unit, registration testing should be considered separately.

If the electrical stimulator is integrated with the connected device, it is usually declared together with the device. Needle electrodes are typically sterile packaged and disposable, and are managed separately as medical devices in the medical device classification catalog, so they can be declared independently.

There are many cases of combination products in active medical devices, and it is common for a product to contain two independent functional modules, each belonging to different classification subcatalogs or classification codes. The product category should be determined according to the higher management category of the two. For classification codes, if a clear definition has been made for such products, the definition document should be followed. If there is no definition, the applicant can determine which module the product is mainly based on and fill in the subcatalog or code of that module; if it cannot be determined, the subcatalog or code of either module can be filled in, and there is no need to apply for a separate classification determination. Taking ultrasonic and high-frequency integrated surgical equipment as an example, the classification code for ultrasonic surgical equipment is 01-01-01, and the classification code for high-frequency surgical equipment is 01-03-01. Both belong to Class III medical devices under the 01 subcatalog, so the overall product category is also Class III. If the main function of the product is ultrasonic surgical equipment, the classification code 01-03-01 can be filled in when applying. If it cannot be determined, 01-00 can also be filled in.

Applicants need to validate or analyze the applicability of the above items. When cross-linked hyaluronic acid gel is not applicable or may not be able to be tested in the finished product, applicants need to provide quality control data on the relevant properties of the intermediate product without cross-linking treatment in the product research materials.

Corresponding to the examples of hydrocolloid dressings or hydrocolloid patches in 14-10-05 of the "Medical Device Classification Catalog" (No. 104 of 2017). Exemption situations do not include: (1) Products that claim indications such as promoting epithelialization, guiding tissue regeneration, promoting wound healing, relieving pain, having antibacterial, anti-infective, antiviral, hemostatic, dissolving necrotic tissue, reducing scarring, preventing adhesion, or acting as artificial skin/skin substitutes, etc.; (2) Products that claim to be suitable for internal wounds, third-degree burns, infected wounds, wounds with a large amount of necrotic tissue, or patients with wound sepsis, etc.; (3) Products containing active ingredients such as drugs/medicinal active ingredients, biological products/biologically active ingredients, silver, disinfectants, etc.; (4) Other novel products, such as those with new materials, new mechanisms of action, or new functions.

The summary materials should clearly state the manufacturer, model, and registration certificate number of the CT. At the same time, it should explain the differences between the CT in the PET/CT system and the CT that has already obtained the registration certificate. Analyze the differences and submit research materials on the impact of the differences on safety and effectiveness. If there is no difference between the CT component and the original registration certificate, research materials for the PET/CT system can be provided without separately providing research materials for the CT component.

Posterior non-fusion spinal fixation systems are used for posterior non-fusion fixation of the spine. They are different from posterior spinal fixation systems used for fusion and should be classified into different registration units. Products with different working principles and structural designs should be divided into different registration units. Products with different main functional materials should be divided into different registration units. If the component materials (such as screws) are different, but the products are used as a whole or in combination, they can be declared as the same registration unit.

No. The mouse embryo assay results are an important indicator for evaluating the safety of such products. According to the requirements within the industry and clinical assisted reproduction for these products, the mouse embryo assay should be specified as a routine quality control item in the product technical requirements.

The following issues should be noted: The summary materials should describe the combination method of the coils when used together, the patient positioning, and the corresponding patient scanning areas; research materials should provide performance study data on signal-to-noise ratio, uniformity, two-dimensional scan layer thickness, spatial resolution, ghosting, etc.; in addition to the performance requirements for individual coils, the product technical requirements should also include the performance requirements when multiple coils are used together; clinical evaluation materials should evaluate the combined coils in conjunction with the applicable scanning areas.

The compatibility of the main unit with the transducer and cutting head of the ultrasound soft tissue cutting and hemostasis equipment greatly affects the safety and effectiveness of the product. The design and development of each part need to be considered as a system. Even if full verification and confirmation of compatibility with other manufacturers' approved products have been conducted during the design and development phase, if the design changes are not promptly understood, it's impossible to conduct a systematic analysis of the design changes. This could lead to safety and effectiveness risks due to compatibility issues. Therefore, an application can be made if there is a clear cooperation relationship with the other manufacturer and it can be ensured that product design changes between both parties can be systematically analyzed; if not, then the application cannot be made.