FAQ

The maximum emission operating mode shall be identified. The operation mode shall comprehensively and detailedly identify the "function'' described in the accompanying document (see article 2.212 of YY 0505 for the definition), and conduct immunity test for each identified function, which shall be conducted in the most unfavorable way to affect the patient.

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“Essential performance” refers to the achievement of performance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the manufacture results in an unacceptable risk.

When determining the essential performance of the product, the administrative counterparts shall consider but not limited to the following aspects:

1. Clinical safety risk;
2. Performance related to diagnosis/treatment/ monitoring;
3. Whether the performance of various sensors, cables, application parts, control devices, display devices, moving parts, etc. are affected by electromagnetic interference.

The essential performance shall be reflected in the accompanying document (product specification) of the product, and the identified essential performance shall be tested for immunity. If the essential performance is not identified, all functions of the product shall be taken as the essential performance for immunity test.

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In general, equipment and devices used in EMC test, cable layout and accessories in typical configuration shall be consistent with those in normal use. If the applicant determines that the inactive accessories are not related to the EMC test after analysis, it is not necessary to test them together with the inactive accessories. The EMC test report shall specify these inactive accessories and the analysis conclusion, and the information of these inactive accessories need not be reflected in the test sample composition table. If the applicant determines that the basic performance of the active medical device must be matched with the inactive accessory after analysis, the electromagnetic compatibility test shall be conducted with the inactive accessories.

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If there are multiple models and accessories in the application registration unit of active medical devices, the administrative counterparts shall take all products (including all models and accessories) in the registration unit as deliveried testing samples, and the EMC test report shall specify the information of deliveried testing samples and tested samples.

If a typical sample is selected for testing after analysis or pre­test, the administrative counterparts shall provide evidence and make a typical model description in the report, and the conclusion of the EMC test report shall clarify whether the sample meets the EMC requirements and standards.

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During product registration and changing registration, EMC test report and electrical safety test report shall be related to ensure that the electrical safety test sample is consistent with the EMC test sample.

During Registration Renewal, if only EMC performance is tested, it is not required to associate with the electrical safety testing report of the previous registration. Because after the product is approved and registered, the administrative counterparts shall organize production according to the approved certificate to keep the product unchanged from the previous registration, so it is not necessary to associate when renewing the certificate.

During the validity period of the registration certificate, if there is any change of the product that does not involve the Change of Permission Items, the administrative counterparts shall carry out relevant verification and validation according to the requirements of the quality management system to ensure that the change does not affect the safety and effectiveness of the product. In addition, when applying for Registration Renewal, it shall state in the statement of no change of products for Registration Renewal: "the change of products shall be controlled through the quality management system, and the items stated in the registration certificate shall not change,^.

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According to "'Guidance for Product Technical Requirement of medical device", the product model and/or specifications shall be clearly defined in the Product Technical Requirements, as well as the description of their division rule. For products with multiple models and/or specifications in the same registration unit, all difference between models and specifications shall be clarified (the corresponding drawings may be attached if necessary). Texts or tables of large scale could also be provided in the appendix.

For stand-alone software or software components, the name, model, release version, and the naming rules of the full version of software also need to be clarified. For the controlling software components, the operating environment (including hardware configuration, software environment and network conditions) is also needed.

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 If the active medical device is used with a general-purpose computer, the computer may not be an composition components of the product, but the requirements of the computer shall be described in the product technical requirements and product instructions.

The product technical requirements shall specify the hardware configuration, software environment and network conditions of the computer, in which the minimum requirements shall be specified for the hardware configuration and network conditions, and the minimum requirements and compatibility requirements shall be specified fbr the software environment. In addition to the above description, the product manual shall also indicate that the computer shall meet the relevant requirements of medical electrical system (GB 9706.15) and electromagnetic compatibility (YY 0505).

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The applicability of cybersecurity for medical device refers to not only the network connection for electronic data transfer and remote control, but also the use of storage media for electronic date transfer.

For medical devices, although there may be no internet connection, while other data transfer ports or data exchange methods could be used(such as USB, RS232, CD-ROM, etc.), which is also applicable to cybersecurity requirements.

In addition, although some medical devices do not have any network connection or physical ports, they can realize data transaction function on the operating user interface. This is also considered as the situation of electronic data exchange, and therefore cybersecurity requirements are needed.

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The "'Guidance for premarket review for medical devices cybersecurity" is applicable to the registration and application of Class II and Class HI medical device products with network connection function for electronic data exchange or remote control and storage medium for electronic data exchange.

The cybersecurity description document is independent of the software description document and shall be submitted separately.

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Android and iOS are incompatible operating system platforms. To add iOS Apps across platforms, it is necessary to be tested with the host, and submit the software research data of iOS Apps according to the '"Guidance for the technical review of medical device software registration”.

If the function of the software does not change and only the operating environment changes, clinical evaluation data may not be submitted; in addition, clinical evaluation data shall be submitted in accordance with the "'Guidance for clinical evaluation of medical devices".

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Active medical devices and the cooperated software are independent medical devices, each with its own registration certificate, and the version of the cooperated software is permission items of the registration certificate of medical devices, so it cannot be changed during the Registration Renewal.

If the medical device is meant to be used with the updated version of the software, it shall apply for the Change of Permission Items, and provide the safety and effectiveness evidence of the cooperation with the new version of the software. If there⁵s no Change of Permission Items submitted, the medical device cannot be used with the new version of software, while still be able to be used with the previous version the software.

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