TX Q&A

An endoscopic surgery system, often referred to as a laparoscopic surgery robot, typically includes a standard composition of a surgeon's console, a patient surgery platform, and an imaging processing platform, used in conjunction with laparoscopes and surgical instruments. Components or accessories that do not have a physical or electrical connection with the system are usually not included in the same registration unit as the system. Dedicated components or accessories that have a physical or electrical connection with the system can be included in the same registration unit as the system. General equipment that is used in conjunction with the system in clinical settings, such as endoscopic cold light sources and high-frequency surgical devices, which connect to the system, are not included in the same registration unit as the system; dedicated disposable accessories that connect to the system can be registered separately.

The applicant should analyze which specific parts of the declared product have changed and provide a detailed description of the changes in the summary materials, as well as provide verification materials for the changes in the research materials. Analyze the impact of the changes on the performance indicators, electrical safety, and electromagnetic compatibility specified in the product technical requirements, and conduct tests on the affected parts.

The positive judgment value for IVD (In Vitro Diagnostic) products should be established and validated before the clinical trial. During the clinical trial, the interpretation of test results should be based on the positive judgment values that have been fully validated. If, based on the clinical reference standard, it is believed during the clinical trial that there is a deviation in the setting of the positive judgment value and it needs adjustment, then after adjustment, new clinical cases should be re-enrolled for the clinical trial.

Changes in matters not specified in the registration certificate and its annexes for in vitro diagnostic reagents do not require a registration change. Enterprises should conduct a thorough risk analysis of the changes and control them through the internal quality management system, ensuring that the changes are fully evaluated, verified, and confirmed to maintain product quality.

The applicant should provide relevant verification materials for the declared product to be used in conjunction with the injection pen. The performance indicators generally include needle hub assembly performance, needle dose accuracy, and needle hub disassembly torque.

Capsule endoscopes are usually intended for single use, and it is recommended that the capsule endoscope be clearly defined as "for single use" in the product structure composition.

Intervertebral fusion devices are mainly used for spinal intervertebral fusion. Products should be divided into different registration units based on the main body material composition (including material grades). According to the commonly used materials for the main body of intervertebral fusion devices, they can be divided into registration units such as Ti6Al4V titanium alloy, PEEK, etc. If the materials of the components (such as contrast wires, self-stabilizing screws) differ, but the products are used as a whole assembly or combination, they can be declared under the same registration unit. Self-stabilizing intervertebral fusion devices and those used in conjunction with internal fixation should be classified into different registration units. Intervertebral fusion devices produced using additive manufacturing processes should be classified into different registration units from those produced using conventional processes (such as machining).

Bacterial resistance gene detection reagents refer to reagents that determine the resistance of target bacteria by detecting specific resistance genes. When conducting clinical research on such reagents, the results of clinical resistance phenotypes should be chosen first as the clinical reference standard for comparative studies. The gene detection results are compared with the clinical resistance detection results to obtain the sensitivity and specificity of the gene detection reagents for detecting resistant bacteria. The performance of the reagent in detecting relevant genes in clinical samples can be confirmed by comparison with gene sequencing or similar products already on the market. For reagents testing resistance genes that are widely recognized in clinical applications and have similar products that have been on the market for many years, clinical trials can primarily be conducted in comparison with similar products already on the market, with some samples further confirmed by comparing with resistance phenotypes. If there are applicable product class guidelines, relevant requirements should be referred to.

Dental handpieces or dental motors with a universal interface compliant with YY 1012 are recommended to be declared for registration separately; dental handpieces without a universal interface should be declared for registration together with the complete unit they are used with, such as dental implant machines, root canal preparation machines, dental comprehensive treatment units, etc.

It is possible to declare the combined scope of application for both the main unit and the accessories, and standardize it by referring to the scope of application for similar products that have already been approved domestically. The scope of application declared should not exceed the scope approved in the country of origin.