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Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.
All information that accompanies an application in accordance with section 5, 6 or 7 must be: (a) legible; and (b) either of the following: (i) in English; or (ii) if it is not in English—be accompanied by a certified translation into English.
Schedule 1—Medical devices other than IVD medical devices
Note: See section 5.