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.
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.
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.
If an imported product includes 10 optional configurations when marketed overseas, but only 3 are selected for sale in China, is this situation acceptable
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.
When specifying the applicable range of a membrane oxygenator based on different user weights, is it necessary to conduct separate clinical trials
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.
How should the registration units of mandibular distractors be divided?
Mandibular distractors are mainly divided into upper jaw distractors and lower jaw distractors, which should be classified into different registration units. If the materials used in the product components (including material brands) are different, they should be classified into different registration units. If the materials of the product components are different but the products are assembled or used together as a whole, they can be declared under the same registration unit.
Can a product have two raw material suppliers?
The application materials need to specify the product's raw material suppliers. If there are two suppliers for the same raw material, the applicant must control the procurement of materials provided by each supplier separately (relevant application materials include quality agreements between raw material suppliers and product manufacturing companies, raw material quality control standards, raw material test reports, qualifications of raw material suppliers, etc.). Products made from raw materials from different sources must undergo separate performance verification/confirmation and risk assessment (including biocompatibility evaluation) to ensure that products made from two different sources of raw materials have consistent performance and meet safety and efficacy requirements. If necessary, the product manufacturing company also needs to conduct on-site audits of raw material suppliers.
How to select typical products for testing blood concentrators?
The selection of typical products includes all raw materials and components, the most complex structure, the highest risk, and the performance that can cover other models of this registration unit, for full project registration testing. For products within the same registration unit, it is recommended to conduct full project testing on the model with the largest membrane area, and then test the physical performance of the model with the smallest membrane area. All components should undergo registration testing, especially those with special structures and performance. After completing the testing of typical products, differential testing can be conducted on other models within the same registration unit.
What should be noted about the types of extraction media for biological experiments?
According to the provisions of the GB/T 16886 series standards, when conducting biological experiments, the selected extraction media should be suitable for the characteristics and use of the final product as well as the purpose of the experiment, taking into account the material chemical properties of the device materials, extractable substances, or residues. For cytotoxicity tests, as serum-containing culture medium is a necessary medium that supports cell growth in the test system and has the ability to extract both polar and non-polar substances, it should be considered as the preferred extraction medium for cytotoxicity tests. In this case, only one extraction medium containing serum culture medium can be used. For sensitization tests, irritation or intracutaneous reaction tests, acute systemic toxicity tests, etc., consideration should be given to selecting both polar and non-polar extraction media. For genetic toxicity tests, according to the GB/T 16886.3 standard, when appropriate, two suitable extraction solvents should be used—one polar solvent and the other non-polar solvent or a liquid suitable for the nature and use of medical devices, and both solvents should be compatible with the test system.
Guidelines for writing Part (V) of the overview information for in vitro diagnostic reagents
In the overview information of the registration application materials for in vitro diagnostic reagents, Part (V) of the summary content, often overlooked, is a summary of the innovativeness of the intended product and the situation of similar products already on the market. This includes the approval status of similar products on the market domestically and internationally, the technical methods and clinical applications of related products, and the similarities and differences between the registered product and similar products domestically and internationally. For newly developed in vitro diagnostic reagent products, literature data should be provided on the relationship between the analyte and the expected clinical indications. If similar products are already on the market domestically or internationally, the applicant should specify the registrant, product name, and quantity of similar products already on the market and compare the differences and similarities between the proposed product and similar products in terms of technical methods, product performance, clinical applications, etc., including the clinical use domestically and internationally. If there are no similar products on the market domestically or internationally, or if the application product changes the conventional expected use and has new clinical diagnostic significance, the applicant should provide literature data on the relationship between the analyte and the expected clinical indications, including relevant guidelines, expert consensus, etc.