Active Device

 When applying for registration of PET/CT products, when CT has obtained a separate registration certificate, the overview material and research data of CT part shall include the following contents: the manufacturer, model and registration certificate number of CT shall be specified in the overview material, and whether there is difference between CT in PET/CT system and CT with registration certificate. If there are differences, the administrative counterparts shall provide the data of difference analysis and submit the research data of the impact of differences on safety and effectiveness. If there is no difference between CT in PET/CT and CT in the original registration certificate, the research data of PET/CT system can be provided and the research data of CT does not need to be provided separately.

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The generator and surgical accessories of high frequency surgical equipment can either be submitted registration as the whole product, or separately.

High frequency surgical equipment used for normal cutting and coagulation is generally considered as commonly universality. If they are submitted separately, the matching situation does not need to be clarified.

The high frequency generator shall clarify its connection port and the rated power, maximum output voltage, and crest factor of each output mode. The high frequency surgical instrument shall clarify its connection port and the maximum rated accessory voltage. If the connection port and parameters from two sides match, they will be able to use together.

For unconventionality used cutting and coagulation function of the high frequency generator and accessories, the matching situation shall be clarified.

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 The compatibility of main engine, transducer and surgical instruments of ultrasound soft tissue surgical equipment will have great influence on the product safety and effectiveness. The design and development of each part needs to be considered as a whole system.

Even if there is sufficient verification and validation on the compatibility with approved product from other manufacturers during design and development, while still not able to timely grasp the design change and carry out systematic analysis, then it will result in the introduction of safety and effectiveness risk due to the compatibility problem.

Therefore, if the administrative counterparts have clear cooperative relationship with the other manufacturers so as to ensure the product design changes between each other can be systematic analyzed, it is possible to apply. If not, the application will not be possible.

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For large-scale imaging equipment (such as CT, MR, PET/CT, etc.), if the third-party physiological gating interface is provided, such as respiratory gating interface, ECG gating interface, etc., the administrative counterparts shall specify the relevant requirements of the third-party gating equipment that can be used together in the overview material, such as interface type (including connection mode, data protocol, etc.), standards that shall be met, etc., If the interface is special, the manufacturer, product model, etc. of the equipment that can be used together shall be specified; the verification and validation data tested together with the third-party equipment shall be provided in the research data; the interface type (including connection mode, data protocol, etc.) and the standard (if applicable) shall be specified in the product technical requirements, the technical parameters related to gating shall be tested.

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The animal experiment mainly provides evidence for the finalization of product design, provides the evidence for the medical device to enter the clinical research stage, and realizes the protection to the clinical subject.

If new mechanism, working principle, structure design, application methods (such as operation), performance improving is adopted, the administrative counterparts should focus on the relevant risk assessment of innovation point, and make verification and/ or validation on the efficacy of risk control methods, therefore to conform whether to carry on the animal experiment referring to the risk management principles.

For example, carbon dioxide laser therapy equipment adopts

new structural design to improve performance, or new functions (such as lattice scanning) for new clinical purposes. When bench performance test research is not sufficient to determine the basic safety of the product, animal experiments should be carried out before clinical trials.

Animal experiments do not have to make control group.

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Please refer to the “Guidance for product registration technical review of medical X-ray diagnostic equipment (Class III)". Clinical parts usually include chest, abdomen, bone and soft tissue, gastrointestinal angiography, aortic angiography, organ angiography, and coronary angiography. The administrative counterparts shall select the applicable parts for clinical trial according to the intended use of the product.

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Software difference may cause difference in product performances, clinical functions and core algorithms. According to the "'Guidance for clinical evaluation of medical devices”, this difference shall be considered in the comparison.

During the comparison, the administrative counterparts shall describe all the difference related to the software in detail and analyze the influence on the safety and effectiveness of the products. If necessary, administrative counterparts shall provide the clinical/non-clinical data of the submitting product itself to prove that the difference has no adverse impact on the safety and effectiveness.

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Comparison with predicate medical device in clinical evaluation fbr active medical device, what content to be compared is relevant to the product features. The performances in the Product Technical Requirement is usually the key indicators describing product features, so generally they will be needed in comparison.

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If the medical electrical equipment is expected to be used in a special environment (such as high temperature, high humidity or low temperature), or if the product performance and clinical effect are easily affected by environmental factors, the supporting data that the product can be used normally and stably in the corresponding environment shall be provided in the research data.

If applicable, the related requirement of GB/T 14710 should be specified in product technical requirement, and the test should be conducted according to requirement.

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First, it is necessary to identify whether the adding models can be regarded as the same registration unit with the original models. If so, application for Change of Permission Items is possible.

In the case of no new standard involved, the judgment principle of typical model should be followed. If the original models can represent the adding models, there is no need to repeat the test for the adding models.

If new standard is involved, the testing report of the adding models for new standard should be provided.

If some items in the testing report of the original model can represent the items of adding models, there is no need to repeat the test in these items.

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 The change of the shell structure and the overall sealing performance of the equipment may lead to the change of the electrical safety and electromagnetic compatibility performance. The administrative counterparts shall conduct an overall assessment of the change of the declared products and analyze the impact of the change on the electrical safety and electromagnetic compatibility performance. If the change has an impact on the above-mentioned performance, or if the standard terms of electrical safety and electromagnetic compatibility need to be re judged or evaluated, the testing shall be carried out; if there is no impact and the relevant terms that need to be re judged or evaluated, the testing may not be carried out.

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