How should the registration units for ventilator products be classified?
A ventilator is a type of lung ventilation device used to automatically increase or provide ventilation to the patient's lungs. According to the "Guidelines for the Division of Medical Device Registration Units," active medical devices based on different technical principles should, in principle, be classified into different registration units. Given the current level of technology, products such as therapeutic ventilators, home care ventilators, emergency and transport ventilators, high-frequency jet ventilators, and high-frequency oscillatory ventilators, which are based on different technical principles, should be classified into different registration units. For therapeutic ventilators that use different technical principles, such as pneumatically controlled ventilators and electrically controlled ventilators, they should be classified into different registration units. Ventilators that have the same technical principle but different product design structures (for example, ventilators with different airway designs) should, in principle, be classified into different registration units. Passive consumables used in conjunction with ventilators (such as breathing circuits, tracheal tubes, masks, etc.) should, in principle, be classified into different registration units from the ventilators.
Can nucleic acid sequence determination, GC-MS/MS, and other laboratory reference methods be entrusted for comparison studies in clinical trials of in vitro diagnostic reagents?
For some in vitro diagnostic reagents that currently lack a clear clinical diagnostic "gold standard" and have no comparable similar products on the market, clinical trial researchers should establish reasonable methods for comparative studies based on existing clinical practices and theoretical foundations. In some cases, where nucleic acid sequence determination, GC-MS/MS, and other laboratory reference methods are used as comparison methods in clinical trials of certain in vitro diagnostic reagents, these methods are not routine clinical testing techniques and require specialized equipment and testing conditions, which clinical trial facilities may not possess. In such situations, applicants should choose clinical trial facilities with the necessary conditions to conduct the trials whenever possible. If some clinical trial facilities lack the testing conditions, they can outsource this testing to specialized sequencing institutions or laboratories with specific testing qualifications, and the results of the testing should be acknowledged. Applicants should submit documents proving the delegation between the clinical trial facility and the commissioned institution, and assess the methodological research and overall quality of the comparative methods. Testing should not be delegated to the applicant's own laboratory.
How should the registration unit of zirconia ceramic blocks be divided
Zirconia ceramic blocks are generally made of zirconia, yttria, hafnia, alumina, and other oxides. They are used in the production of crowns, bridges, inlays, veneers, and other restorations for fixed dental prostheses. Products with different main components should be divided into different registration units; products with different key performance characteristics such as flexural strength, sintering density, shrinkage/expansion rate, and translucency due to different compositions should be divided into different registration units; products produced using different forming processes should be divided into different registration units, for example, zirconia blocks produced using the "slip casting" process and the "dry pressing" process should be considered separate registration units. Zirconia ceramic blocks with the same composition and process but different shapes or sizes can be declared as a single registration unit.
Criteria for selecting typical products for bilirubin plasma adsorbers during testing
For comprehensive registration testing, select products that include all raw materials and components, have the most complex structure, pose the highest risks, and have performance characteristics that can cover other models within the same registration unit. For products within the same registration unit, it is recommended to conduct comprehensive testing on the largest capacity adsorber model, while also testing the physical performance of the smallest capacity adsorber model.
How to consider the biocompatibility requirements of dental equipment accessories
Dental handpieces, spray guns, and other oral devices used in clinical settings involve parts like the handpiece and nozzle coming into contact with oral tissues during operations, necessitating a biocompatibility assessment. Applicants should describe the materials in contact with oral tissues, as well as the nature and duration of contact during use. Referring to the "Notice on Issuing the Guidelines for Biological Evaluation and Review of Medical Devices" (National Food and Drug Administration [2007] No. 345), if a company submits a declaration stating that no reevaluation as stipulated in Article 4(1) of Appendix 1 has occurred, a biological evaluation does not need to be conducted again. Otherwise, the biocompatibility assessment should be carried out in accordance with the requirements of National Food and Drug Administration [2007] No. 345, GB/T 16886.1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Processes," or YY/T0268 "Biological Evaluation of Dental and Oral Medical Devices Part 1: Evaluation and Testing."
Do ophthalmic adhesive products have to be sterilized by terminal sterilization methods, or can they undergo aseptic processing without terminal sterilization?
It is recommended that such products prioritize terminal sterilization methods. If terminal sterilization is truly not feasible for the product, consideration can be given to aseptic processing methods such as filtration for sterilization control. However, documentation should be provided to prove the rationale for choosing aseptic processing for such products. Additionally, the applicant must describe the quality assurance system and sterilization methods used to ensure product sterility and provide corresponding verification data.
Do EMC testing reports for renewal registration need to be related to the electrical safety testing reports from the initial registration?
The association of EMC testing reports is to ensure the consistency between the safety testing reports and the test samples used in the EMC testing reports. After product registration approval, the registrant should organize production in accordance with the approved content to ensure that the product remains unchanged. Therefore, there is no need for association during renewal registration. During the validity period of the registration certificate, if there are corrective actions that do not involve licensed changes to the product, the registrant should conduct relevant verification and confirmation work in accordance with the requirements of the quality management system to ensure that the corrective actions do not affect the safety and effectiveness of the product. When applying for renewal registration, it should be stated in the "Declaration of No Changes in Products for Renewal Registration" that "changes to the product are controlled through the quality management system, and there are no changes to the items listed on the registration certificate."
Can you apply for reagent registration if the supporting dedicated instrument for a newly developed reagent has not obtained a registration certificate?
For newly developed in vitro diagnostic reagents and their supporting dedicated instruments, as they fall under different regulatory management, separate registration applications need to be submitted. However, the verification and confirmation of the testing performance of the reagents and their dedicated instruments are integral parts of the overall validation process. Therefore, when both the reagent and the instrument are finalized, the order of market entry for the reagent and its supporting dedicated instrument is not restricted. When applying for reagent registration, it should be ensured that the dedicated instrument and the detection system are finalized. If instruments produced by other companies are used, these supporting instruments should already be on the market as medical devices in China, and comprehensive verification and confirmation of their performance on these supporting instruments should be possible.
Can the establishment of extraction limits in soft contact lens products be based on the submission of extraction research reports for similar products?
Applicants should establish extraction limits in accordance with the requirements of the extraction test in GB11417.3 and provide evidence, recommending reference to the "Notice on Relevant Issues in the Evaluation of Contact Lens Products" published on our center's website in 2016 and the document "Interpretation of the Expression of 'New Materials' in the National Standard Series GB11417 'Ophthalmic Optics Contact Lenses' and the Applicable Tests" issued by the National Medical Optics and Instrumentation Standardization Sub-Technical Committee in 2017. It is suggested to submit extraction research reports for the declared products. If you intend to submit extraction research reports for similar products as a basis, it is recommended that the formulations of both products are similar, such as only having differences in dye content, and it is not advisable if there is a significant difference between the formulations of the comparative product and the declared product. Additionally, it is recommended to demonstrate the similarities and differences between the selected product and the declared product, discussing aspects such as raw material formulations, product dry weight, and the wearing period of the product, analyzing whether these differences affect the results of the extraction study. Finally, attention should be paid to reasonably establishing the upper limit of the extraction rate.
How should the registration units for synthetic resin denture products be divided?
Synthetic resin teeth are mainly made from acrylic ester polymers and are used in the production of partial and full dentures, replacing missing or damaged teeth to form an artificial dental arch, restoring the external shape of teeth, and chewing function. Products with different main chemical compositions should be divided into different registration units, while products with only different color shades can be declared as a single registration unit. Products with different key production manufacturing processes and forming methods should be divided into different registration units (such as compression molding, injection molding, 3D printing, CAD/CAM, etc.). Products with different key performance indicators due to different modification mechanisms from traditional materials should be divided into different registration units (e.g., surface hardness, wear resistance, etc.). Products with different clinical application technologies should be divided into different registration units.