What kind of documentation should be submitted to prove the hemostatic mechanism of absorbable hemostatic products?
Applicants should submit technical or evidential documentation that effectively proves or elucidates the hemostatic action principle of the declared product. Applicants should elaborate in detail on the hemostatic mechanism of the product, describe how the product affects the hemostasis process, the product's advantageous role during hemostasis, and confirm whether the combination of this hemostatic mechanism with the declared product application is scientifically reasonable. Review domestic and international research literature supporting this hemostatic principle and submit the original scientific literature and its Chinese translation that specifically support this hemostatic principle. Clarify whether there are already products applying the same hemostatic principle on the market domestically and abroad, and research whether the declared product might cause adverse reactions related to its use, such as thrombosis formation, coagulation disorders, etc.
How should products used for cranio-maxillofacial internal fixation and repair be classified into registration units?
Based on the different applicable scopes and structural compositions of the products, they can be divided into different registration units such as cranio-maxillofacial bone plate systems, cranial locks, titanium meshes, and artificial cranial implants. Based on the different materials used in the products (including material grades), they can be classified into registration units such as TC4 titanium alloy, TC4ELI titanium alloy, TC20 titanium alloy, TA2 pure titanium, TA3 pure titanium, TA4 pure titanium, etc. If the materials of the product components differ, but the products are used as a whole assembly or combination, they can be declared under the same registration unit.
The selection of comparative reagents/methods in clinical trials of in vitro diagnostic reagents
According to the "Technical Guidance Principles for Clinical Trials of In Vitro Diagnostic Reagents," for newly developed in vitro diagnostic reagents, the test in vitro diagnostic reagent should be blindly compared synchronously with the "gold standard" for diagnosing that disease. For products that are "already approved and on the market," an existing market product can be chosen as the comparative reagent. It's important to fully understand the technical information and performance of the selected product/method, such as methodology, clinical intended use, main performance indicators, traceability of calibration materials, positive judgment values or reference ranges, etc. Consider the comparability between the comparative reagent/method and the test in vitro diagnostic reagent thoroughly, and choose an appropriate comparative reagent/method for the trial. This is to verify the clinical performance of the test in vitro diagnostic reagent through comparison.
How should the scope of application for single-use light-protective infusion devices be determined?
Registrants should simulate the worst clinical use conditions and conduct a drug compatibility assessment for each drug solution claimed in the scope of application, examining the interaction between the infusion device and the drug solution. This includes unilateral or mutual substance migration, adsorption, quality changes, and the light-protective effect of the infusion device. Based on the conclusions of the drug compatibility assessment, the scope of application for the product being registered should be determined.
The classification of registration units between locking metal orthopedic plates and non-locking metal orthopedic plates
Locking metal orthopedic plates and non-locking metal orthopedic plates belong to different registration units and must be declared separately. Accessories used in conjunction with locking metal orthopedic plates, such as locking metal bone screws, locking metal hollow screws, screw caps, washers, and fixation clips, can be registered together with the metal orthopedic plates as part of an orthopedic plate system. If a locking metal orthopedic plate includes non-locking holes, non-locking metal bone screws can be classified within the same registration unit as the plate.
The confirmation of inconsistent sample results in clinical trials of in vitro diagnostic reagents
The clinical trial protocol should clearly define the criteria for determining samples with inconsistent results between the test in vitro diagnostic reagent and the comparative reagent. Samples determined to have inconsistent results during the clinical trial should be reviewed using a "gold standard" or another reasonable method, and the protocol should specify the "gold standard" or method used for review. The clinical trial report should present the final confirmed results or judgments, and if no review is necessary, the reasons should be detailed.
Do polyurethane foam dressings with adhesive backing qualify for the exemption from clinical trials in the Class III medical devices category as polyurethane foam dressings?
They are included in the catalog, but please note that the exemption does not apply to the following four situations: (1) Products that claim to promote epithelialization, guide tissue regeneration, enhance wound healing, relieve pain, stop bleeding, reduce scarring, prevent adhesion, etc.; (2) Products claimed to be suitable for internal wounds, third-degree burns, infected wounds, wounds with a significant amount of necrotic tissue, patients with wound sepsis, etc.; (3) Products containing active ingredients: such as drugs/medicinal active ingredients, biologics/biological active ingredients, silver, disinfectants, etc.; (4) Other novel products.
For degradable/absorbable implantable medical device products, can research institutions' publicly published literature be provided as research material for the product's degradation performance?
For mature materials, applicants can submit publicly published literature by third parties as supportive material for the study of degradation product metabolism. However, since performance indicators and observation time points in the study of product degradation cycles are related to product design, applicants should conduct experimental research on the product degradation cycle.
Which medical devices do the cybersecurity guidelines apply to? Can cybersecurity documentation be submitted within the software description document?
The cybersecurity guidelines are applicable to the registration applications of Class II and Class III medical devices that have networking capabilities for electronic data exchange or remote control. This includes devices connected through both wireless and wired networks, with electronic data exchange encompassing both one-way and two-way data transmission, and remote control including both real-time and non-real-time control. Additionally, the guidelines also apply to Class II and Class III medical devices that use storage media for electronic data exchange in their registration applications. The storage media include, but are not limited to, CDs, external hard drives, and USB drives. Cybersecurity documentation should be submitted separately.
How to Apply for Changes in the Content of Medical Device Instructions?
According to the "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the General Administration), if there is a change in registration for an already registered medical device, the applicant should modify the instructions and labels according to the change document after obtaining it. For changes in the content of the instructions that are not within the scope of registration change, they can be made through the medical device instruction change notification procedure. When submitting the application for a change notification of medical device instructions, the registrant should also submit supporting documents for the change content. If the registrant does not provide sufficient supporting documents or the supporting documents are insufficient during the formal review process, the formal review will inform the registrant of the specific problems in the declared materials and the documents that need to be submitted by the registrant through correction opinions.