How should dental adhesive products be classified for registration units?
Dental adhesives are used for securing removable partial dentures, overlay dentures, and other types of dental restorations. Products with different structural compositions should be classified into different registration units. For example, post-type, bar-clip type, attachment type, and ball cap type attachments should be classified as different registration units.
When software undergoes changes, in what situations should a registration application be submitted?
According to the "Guiding Principles for the Technical Review of Medical Device Software Registration," significant software updates (i.e., changes in software release versions) require reporting changes in the license application. For minor software updates, manufacturers can control them through the quality management system without the need for registration changes. The relevant declaration materials should be submitted at the next registration (registration change and renewal registration).
Regulatory Understanding of Changes in Main Material Suppliers of In Vitro Diagnostic Reagents "Antigens, Antibodies, etc."
Article 58 of the "Regulations on the Registration and Management of In Vitro Diagnostic Reagents" (Decree No. 5) stipulates: "If there are changes in the content stated on the registration certificate and its attachments, the applicant shall apply to the original registration department for changes in the license application, including changes in the main material suppliers of antigens, antibodies, etc." The interpretation of this provision is as follows: 1. Changes in the license application pertain only to the content stated on the registration certificate and its attachments, specifically the changes in the main raw material suppliers clearly stated in the appendix of the product's technical requirements. Changes in main raw material suppliers not explicitly stated in the registration certificate and its attachments, such as in the case of Type II in vitro diagnostic reagents where there is no appendix in the product's technical requirements, require the applicant to conduct their own research and quality control when changes occur in the main raw material suppliers without the need to apply for changes in the license application. 2. The situation of "changes in main material suppliers of antigens, antibodies, etc." is limited to changes in the main raw material suppliers. Changes in the main raw materials themselves, such as changes in the antibodies themselves, do not fall under the category of changes.
What are the common points to note in the subchronic toxicity test report for biological evaluation?
For evaluation indicators showing statistical differences in the test, the test report should clearly indicate whether these differences have biological significance and provide reasons, analyze the relationship between the relevant differences and the test product, rather than just listing the items with statistical differences. Additionally, for subchronic toxicity tests involving implantation contact with the test substance, the basis for determining the implantation dose should be provided. For example, in cases where animals can tolerate it, the recommended sample implantation dose is 50-100 times the intended human clinical dose.
How to evaluate the safety of DEHP in a disposable blood dialysis tubing made from DEHP plasticized PVC raw materials?
Select a complete set of tubing with the highest DEHP content, use a suitable extraction solution (such as ethanol-water) and testing methods to simulate the most stringent clinical conditions (e.g., according to the chemical performance test liquid preparation method specified in YY 0267 "Chemical Properties Test of Cardiovascular Implants and Extracorporeal Circulation Blood Circuit of Blood Purification Devices," circulation at 200mL/min flow rate and 37°C for 5.5 hours under the maximum blood flow rate claimed for clinical use), and test the total amount of DEHP leached. Provide an analysis of the toxicity, safety limits, and source documents for human blood contact with DEHP, and evaluate the safety for different weight-appropriate populations based on physiological characteristics.
Do clinical trials need to be conducted when adding new functional parameters to patient monitor products during registration changes?
1. If the newly added functional parameters are equivalent to products listed in the "Exempt from Clinical Trial Catalog," they can be evaluated according to relevant clinical evaluation requirements. 2. If the patient monitor with the new functional parameters belongs to the same category of medical devices, it can be evaluated through clinical assessment. If overseas data for the new functional parameters comply with the "Guiding Principles for Accepting Overseas Clinical Trial Data for Medical Devices," relevant clinical data can be provided. 3. If the patient monitor with new functional parameters cannot be clinically evaluated through the above methods, consideration should be given to conducting clinical trials to confirm the product's scope of use.
How should the registration units of dental retraction materials be divided?
Dental retraction materials are a type of auxiliary material used in oral treatment, for retracting the gums during tooth preparation, impression taking, or crown adhesion. Products with different main chemical compositions should be divided into different registration units. Products with different characteristics leading to different clinical application techniques should be classified into different registration units, such as retraction cords and retraction pastes should be separate registration units. Products with vasoconstrictor or hemostatic functions and those without should be separate registration units.
What data needs to be submitted for soft contact lens products using non-spherical optical design to improve optical imaging?
In addition to the standard registration application materials, it is recommended to focus on the following research data for non-spherical optical design: 1. Optical design and principles of non-spherical design. 2. A comprehensive description of the production technology to achieve non-spherical design. 3. Verification data proving the non-spherical design of the lens. 4. If a company intends to promote the product's non-spherical design for improved optical imaging in the proposed instructions, corresponding project requirements, test methods, and a testing report should be included in the product's technical requirements.
Can the same raw materials as the final product be used for biocompatibility testing?
Biological evaluation should consider factors such as the materials used in manufacturing the product, expected additives, process impurities and residues, leachables, degradation products, physical characteristics of the final product, interactions between components and their presence in the final product, packaging materials, and the impact of storage media on biocompatibility. Therefore, biocompatibility testing of the product should ideally be conducted using the final product or representative samples taken from the final product. If testing with the final product is not feasible, samples produced using the same manufacturing process as the final product can be considered for testing, but the representativeness of the samples should be thoroughly analyzed and demonstrated. Additionally, when a device has different component materials, consideration should be given to possible chemical reactions between the different components and their combined effects on the human body when selecting test samples. However, if different components of a medical device have varying levels of contact with the body and different contact durations, biological testing should be conducted separately.
How should the registration units of dental tray polymer products be divided?
Dental tray polymer materials are polymer base materials used for making denture trays and orthodontic trays. Products with different main chemical compositions should be divided into different registration units. Products that only differ in color or have added fiber components for aesthetic and performance modifications can be considered as one registration unit. Products with different polymerization mechanisms should be divided into different registration units, such as products with multiple polymerization methods for one material being considered as one registration unit. Products with different key performance indicators should be divided into different registration units. Products that must be used together inseparably to achieve the intended purpose can be considered as one registration unit.