TX Q&A

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.

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.

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.

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 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.

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 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.

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.

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.

According to the "Guidelines for Writing Technical Requirements for Medical Devices," the technical requirements should clearly specify the product models and/or specifications, as well as the explanation of their division. For products within the same registration unit that come in various models and/or specifications, it should clearly delineate all differences between each model and specification (if necessary, corresponding illustrations can be provided for clarification). For models/specifications with extensive descriptive text, an appendix format can be utilized. For standalone software or products containing software components, it should also specify the software's name, model specifications, release version, and the naming rules for the complete version. For control-type software components, the operating environment should also be clearly defined (including hardware configuration, software environment, and network conditions).