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System or procedure packs
Information for manufactures and sponsors of medical device systems or procedure packs.
Two or more goods will be a system or procedure pack if:
- at least one of the goods is a medical device; and
- either:
- all of the goods are to be interconnected or combined for use in a medical or surgical procedure (i.e. regardless of whether the goods or some of the goods are packaged together or not); or
- all of the goods are packaged together for use in a medical or surgical procedure (i.e. regardless of whether the goods or some of the goods are to be interconnected or combined for use in the medical or surgical procedure).
Goods that are interconnected or combined for use, or packaged together, but not for the purpose of being used in a medical or surgical procedure would not constitute a system or procedure pack.
Please read the information provided in the links below for more detailed information.