TX Q&A

According to Article 16 of the "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6): "When a registered medical device undergoes a registration change, the applicant must modify the instructions and labels according to the change document after obtaining it. If there are other changes in the instructions, the applicant must inform the medical device registration approval department in writing and submit relevant documents such as a comparison explanation of the changes to the instructions."

During the design and execution of clinical trials for in vitro diagnostic reagents, special attention should be paid to the consistency between the operational details in the clinical trial process and the related product instructions. This includes the instructions for the in vitro diagnostic reagents used in the trial, comparative reagents, and review reagents. For both the trial-specific in vitro diagnostic reagents and the comparative and review reagents used, the aspects of the instructions that should be particularly focused on in clinical trials include the intended use, applicable sample types, sample anticoagulants, sample preservation and handling requirements, sample processing reagents (such as nucleic acid extraction reagents) and other supporting reagents, applicable machine types, test methods, criteria for interpreting results, limitations, etc. During the clinical trial design process, detailed standard operating procedures should be established according to the relevant instructions to ensure that the testing of comparative and review reagents during the clinical trial is conducted strictly in accordance with the instructions. The clinical trial testing process and results for the trial-use in vitro diagnostic reagents should support the claims made in the product instructions of the product intended for registration.

Referencing the "Guidelines for Technical Review of Medical Device Cybersecurity," electronic data exchange methods include wireless and wired networks, unidirectional and bidirectional data transmission, and real-time and non-real-time remote control and storage media. Exchanging video data through a non-wired method falls under electronic data exchange and should adhere to the corresponding network security requirements.

If the anodizing is conducted by the applicant, they must submit their own anodizing process documentation, including cytotoxicity, surface element qualitative analysis, and process validation data. If the anodizing is outsourced to a third party, in addition to providing the third party's recognized anodizing process documentation, the applicant must also submit documents reviewing the third party's anodizing process, including quality control requirements and the basis for these requirements.

It is recommended to analyze the differences between each model of the declared product based on its intended use, the objectives of the clinical trial, and evaluation indicators. Combine these findings with the results of the declared product's model specifications to comprehensively assess whether the model specifications used in the clinical trials can represent all model specifications of the declared product.

The usage period of standalone software is determined by commercial factors. The lifespan of software components is the same as that of the medical devices they are part of, and does not need to be separately indicated. The lifespan requirements for specialized standalone software are considered the same as those for standalone software and are reflected in the lifespan research materials of the medical devices they belong to.

Disposable ligation clips need to deliver the right amount of closure force when clamping tissue. If the force is too low, it's not effective for stopping bleeding, and if it's too high, it can cause ischemic necrosis at the tissue ends of the closure, hindering wound healing. Bench tests usually use latex, silicone tubes, or ex vivo tissues/vessels instead of human blood vessels. However, these cannot fully simulate the conditions of blood vessels during and after surgery, such as the structure of the vessel walls, and postoperative pathophysiological states like inflammation, edema, and fibrosis. Therefore, they can't adequately assess the product's effectiveness and safety, making animal testing necessary.

For orthopedic metal implants, colored anodized products and non-colored products can be interchangeable, and a typical model/worst-case scenario can be selected for testing/performance studies. Non-colored/colored anodized products and micro-arc oxidized products are not interchangeable, and typical models/worst-case scenarios should be selected separately for testing/performance studies.

In vitro diagnostic reagents that are exempt from clinical trials should include calibration and quality control materials in the selected comparison reagent composition during clinical evaluation, or the approval documentation for the comparison reagents should explicitly specify the corresponding calibration and quality control materials. During the experimental operations, it is crucial to strictly follow the instructions of the comparison reagents for calibration and quality control to ensure the reliability of the test results.

According to the YY/T 0719.5-2009 standard for the physical compatibility test between contact lens care products and contact lenses, for daily-use contact lens care products, 30 cycle operations are required. For products used as part of the care process (such as enzyme cleaners), the number of cycles should represent a month's use or at least 5 cycles. These recommended cycle numbers should be clearly specified in the test methods of the product's technical requirements.