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Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
Division 1Class I medical devices that are intended to be supplied in a non-sterile state and do not have a measuring function
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Division 1—Class I medical devices that are intended to be supplied in a non-sterile state and do not have a measuring function
| Column 1Item | Column 2Regulatory authority | Column 3Declaration of conformity in relation to the medical device | Column 4Conformity assessment document relating to the medical device |
|---|---|---|---|
| 1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations |