Submit your application for inclusion of a medical device

Information about the application process and forms.

Different steps apply for different categories and types of devices.

More information is outlined in the Medical device inclusion process.

Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices

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Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices.
Submitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)

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Submitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only).
Submitting 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)

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Submitting 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).

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