TX Q&A

For polyurethane foam dressings that meet the conditions of the "Revised Catalog of Medical Devices Exempt from Clinical Trials," applicants should submit comparative data between the declared product information and the content described in the catalog, as well as a comparative explanation of the declared product with domestically registered medical devices approved in the catalog and corresponding supportive data. For polyurethane foam dressings not within the scope of the exemption list, applicants should, while meeting the requirements of registration regulations, select appropriate clinical data of similar products according to the "Technical Guidance Principles for Clinical Evaluation of Medical Devices" for clinical evaluation and issue a clinical evaluation report as required by these guidelines. Applicants can also confirm the safety and effectiveness of the product's clinical application through clinical trials. If conducting clinical trials, considerations should include the purpose of the clinical trial, study population, selection of control groups (if necessary), sample size estimation, evaluation of assessment indicators and quantification methods, statistical analysis methods, and other related aspects.

According to the "Notice of the General Administration Office on Issues Related to Textual Changes in the Instructions for In Vitro Diagnostic Reagents" (Food and Drug Administration Equipment Management [2016] No. 117), textual changes in the informative content of instructions for in vitro diagnostic reagents can be modified by the registrant themselves, including the "Interpretation of Labeling" section in the instructions for in vitro diagnostic reagents. If the registrant improves the interpretation of corresponding labels in the instructions for in vitro diagnostic reagents according to the YY/T0466 series of standards, resulting in changes to this content but not involving other changes requiring permission, the registrant should make the modifications themselves. Here, the YY/T0466 series of standards refers to either the YY/T0466 series of standards or the corresponding ISO 15223 standard. If the registrant makes modifications themselves, they should provide an explanation upon renewal of registration.

Dental implants are medical devices implanted in the jawbone through surgical procedures to support denture restorations. Implants with different body materials should be classified into different registration units; implants with different surface treatment methods should be classified into different registration units; implants with different compositional structures should be classified into different registration units; implants with different forming processes should be classified into different registration units. Implant systems that must be used together inseparably to achieve the intended purpose can be declared as a single registration unit.

When a foreign product is registered for application in China, the scope of the application should not exceed the approved scope overseas. If only a portion is declared, and that part can be independently applied while ensuring safety and effectiveness, reductions can be made to the approved scope overseas.

If clinical trials are to be conducted for a registered product, it is recommended to conduct separate clinical trials for users with a weight >10kg and ≤10kg based on the specified applicable range of the membrane oxygenator. For manufacturers applying for registration of membrane oxygenators for users of different weights, it is suggested to first complete the registration of membrane oxygenators for users with a weight >10kg from a safety and effectiveness perspective. Once the product for users with a weight >10kg is on the market, then develop membrane oxygenators for users with a weight ≤10kg. Upon completing the technical documentation, risk management information, registration testing, etc., the number of clinical validation cases for membrane oxygenator products for users with a weight ≤10kg should be no less than 80 cases. When validating the population with a weight ≤10kg, a single-group target value trial design can be adopted.

Dental impression materials are used to make negative molds that record the morphology and relationships of oral tissues. Products with different materials should be classified into different registration units, for example, dental silicone rubber impression materials and dental alginate impression materials should be separate registration units. Products with different polymerization reaction mechanisms should also be classified into different registration units, such as addition-cure silicone rubber and polyether-type silicone rubber should be separate registration units.

It is possible to submit data from overseas multicenter clinical trials as clinical evaluation data for the product. According to the "Technical Guidance Principles for Accepting Overseas Clinical Trial Data of Medical Devices," it should be demonstrated that the clinical trial data can prove the safety and effectiveness of the product for use in China. Acceptance of overseas clinical data should adhere to ethical principles, legal principles, and scientific principles, taking into account differences in technical review requirements, differences in the study population, and differences in clinical trial conditions. Ethnic differences are just one aspect to consider.

If the sterilization-related risks related to materials, structural composition, primary packaging, biological load, etc., of the product being applied for can be covered by those of similar products, applicants can utilize sterilization confirmation reports from similar products as supporting documentation. However, special attention should be paid to the impact of differences on the coverage of sterilization risks. When applying, documentary evidence that supports the use of sterilization confirmation reports from similar products and their sterilization confirmation reports should be submitted simultaneously.

Dental orthodontic wires are filamentous solids used to correct dental malocclusions, often used in combination with brackets, bands, buccal tubes, etc. They are commonly made of materials such as stainless steel, nickel-titanium alloy, titanium alloy, titanium-molybdenum alloy, copper-nickel-titanium alloy, etc. Products with different materials should be classified into different registration units, for example, orthodontic wires made of polymer materials and those made of nickel-titanium alloy should be separate registration units. Products with different key performance indicators should also be classified into different registration units.

It is recommended that applicants analyze the substances that may cause human immune reactions in the final product from aspects such as product material sources, immunogenicity control processes, and product performance, such as DNA, RNA, α-Gal antigen, phospholipids, heterologous proteins, polysaccharides, etc. When appropriate, representative substances can be selected for qualitative and quantitative testing, and controlling their residual amounts can be one of the requirements for product immunogenicity quality control.