How should the registration units of dental impression material products be divided
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.
For international multicenter clinical trials that include data from China to be used as clinical data for overseas market approval, is it feasible to directly submit this trial data for approval in China without discussing ethnic differences
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.
Can applicants use sterilization confirmation data from other similar products to support their application for sterilization confirmation reports
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.
How should the registration units of dental orthodontic wire products be divided
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.
What information needs to be submitted for soft corneal contact lens products using non-spherical optical design to improve optical imaging
It is recommended to submit the following information: 1. Non-spherical optical design and working principles; 2. Complete description of the production technology for implementing the non-spherical design; 3. Verified testing methods for the non-spherical design and corresponding test results; 4. If a company further promotes in the instructions that the non-spherical design of the product can improve optical imaging, corresponding project requirements should be established in the product technical requirements and a testing report should be issued.
How should the registration units of glass ionomer cement products be divided
Glass ionomer cement is a dental material used for adhesive bonding, cavity lining, base, and filling in oral restorations. Products with different main chemical compositions should be classified into different registration units. Products with different key performance indicators, expected clinical use methods, and clinical applicability ranges should be classified into different registration units. Products with different reaction mechanisms should be classified into different registration units. If a product has multiple clinical uses, it can be considered as the same registration unit. Products that need to be used together to achieve the intended purpose can be considered as the same registration unit.
How to select clinical trial samples when the reference values in the reagent kit instructions involve different age distributions
During the clinical trial design process, in addition to focusing on the total number of cases, the distribution of positive and negative cases, and interfering cases, attention should also be paid to the necessary requirements for case grouping and stratification. If the reference values in the reagent kit vary across different age groups, when selecting cases for inclusion, the differences in age groups should be considered. Statistically significant numbers of individuals from different age groups should be included, ensuring a balanced ratio of positive and negative cases in each age group. If there are multiple age segments in the reference values, the total number of cases included based on the above requirements may exceed the minimum sample size required by the "Guidelines for Clinical Trials of In Vitro Diagnostic Reagents."
Can products in the "Catalog of Class III Medical Devices Requiring Clinical Trial Approval" be declared using overseas clinical trial data? Do clinical trials still need approval in China?
According to the "Technical Guidelines for Accepting Overseas Clinical Trial Data of Medical Devices" released in January 2018, medical devices listed in the "Catalog of Class III Medical Devices Requiring Clinical Trial Approval" (referred to as the "Catalog") can also be declared using overseas clinical trial data as required by the above guidelines. For products in the "Catalog" that require clinical trials in China due to overseas clinical trial data not meeting the corresponding requirements, clinical trials still need to be approved before they can proceed.
How should dental fiber post products be divided into registration units
Dental fiber posts are polymer composite products reinforced with fibers, used in clinical dental treatments by placing them into root canals that have undergone root canal treatment. They securely bond to the inner walls of the root canal through adhesives, forming the foundation for crown core and tooth crown fixation. Products with different main chemical compositions should be classified into different registration units, such as carbon fiber posts, glass fiber posts, quartz fiber posts, and polyethylene fiber posts should be separate registration units. Products with different manufacturing processes should be divided into different registration units, such as fiber posts produced using fiber extrusion processes and those produced using CAD/CAM processes should be separate registration units. Products with different application technologies should be divided into different registration units, such as prefabricated fiber posts and semi-prefabricated fiber posts should be separate registration units.
What are the hardness requirements for components of the stapler
According to the "Guidelines for Technical Review of Stapler Products Registration," components made of 20Cr13 material should undergo heat treatment, with a hardness of 40HRC-48HRC; the hardness of the cutting blade should not be lower than 377HV0.2. Manufacturers can also determine the hardness of components and cutting blades based on the performance of their own products, but they need to provide complete verification data for proof.