TX Q&A

When describing the computer configuration in the product technical requirements, such as CPU frequency, storage space, memory space, display resolution, etc., you can describe the minimum requirements for the configuration. When upgrading the computer configuration, validation of relevant design changes can be carried out through the quality management system. If it does not involve changes in product technical requirements, there is no need for changes in licensing registrations.

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.

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.

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."

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.

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.

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.

When conducting joint testing for multiple analytes, the first consideration should be whether these analytes have synergistic diagnostic significance. The joint testing products should be able to target the same applicable population and indications, taking into account the clinical application's joint testing requirements and necessity. It is not recommended to design joint testing reagents for multiple analytes that do not have synergistic diagnostic significance. Different combinations of multiple analyte test kits can be considered as the same registration unit. Different combinations are limited to cases where the detection reaction systems for each individual test are relatively independent and not mixed. For example, drug testing paper strips, five individual test paper strips, and three or four-item joint test cards. Whether it is joint testing or individual testing, the detection of each item is relatively independent and does not interfere with others. If submitted as the same registration unit, providing all technical data for all five items should cover all products. For different combinations of joint testing reagent kits, the product names can be unified based on the relevant indications, such as combining a three-item joint testing reagent with a five-item joint testing reagent as the same registration unit, named as a multi-drug joint detection reagent kit (colloidal gold method). However, individual test reagent kits cannot be unified with multi-analyte test kits due to differences in product names and usage. For example, multi-analyte test reagents using chip hybridization methods or PCR methods for each analyte in separate reactions. Cases where the reaction systems for each analyte are mixed do not fall under the above situations, such as PCR reagents where multiple analytes are mixed in one reaction system. If the product registration unit includes different combinations of multiple joint tests, registration inspection/outsourced inspection and clinical evaluation should use specifications for the most comprehensive item combinations, and product performance research data should cover all analytes being tested.

A comprehensive assessment of the changes in the declared product should be conducted. If changes like alterations in the casing structure or sealing performance involve the need for a reassessment or evaluation of electrical safety standards or electromagnetic compatibility standards, testing should be carried out.

For product components that are not regulated as medical devices, they cannot be individually registered, but they can be considered as part of the medical device. If this component is declared as part of the medical device, it should be evaluated as part of the whole, and corresponding testing and verification should be conducted along with the entire device. If the applicant does not declare this component or does not test and verify it along with the whole device, it cannot be approved as part of the product. For example, printers, cables, endoscope illumination cables, neutral electrode connection cables, and similar components fall into this category.