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The Active Medical Device Contains The APP Software Used By Users. If The Android APP Is Registered, Is It Necessary To Be Tested When Adding IOS APP? Is Clinical Evaluation Data Required?

2022-10-30

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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