Different steps apply for different categories and types of devices.
More information is outlined in the Medical device inclusion process.
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PageSubmitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices.
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PageSubmitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only).
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PageSubmitting an application in TBS (for all classes except Class I non-sterile, non-measuring medical device, Class 1 IVD medical device and Class I medical device/Class 1 IVD medical device Export Only).