Principles for determining typical products for registration testing within the same registration unit for initial registration and license change of medical suture needle products
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.
When applying for registration of PET/CT products, if the CT component has already obtained a registration certificate, how should the CT-related summary materials and research materials be provided?
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.
Which situations are not included in the clinical exemption for hydrocolloid dressings?
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.
Regarding the requirements for shear viscosity and molecular weight distribution coefficient in YY/T0308-2015 "Medical Sodium Hyaluronate Gel", how should injectable cross-linked sodium hyaluronate gel products refer to them?
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.
Can the electrical stimulator and needle electrodes of intraoperative EEG/EMG/evoked potential measurement systems and other devices be registered 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.
How should the registration units for posterior non-fusion spinal fixation systems be divided?
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.
What issues should be considered in the registration materials when multiple receiving coils are used together in a magnetic resonance imaging system?
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.
How should artificial vertebral body product registration units be divided?
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.
How to solve the problem of difficulty in obtaining H5N1 subtype cases in clinical trials of influenza virus detection reagents.
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.
Should infusion needleless connectors undergo microbial ingress evaluation?
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.