Recently, RANZCO made two submissions to the Therapeutic Goods Administration (TGA) proposing changes that would help to improve eye health care. The submissions included the following:
RANZCO submission to consultation: Proposed changes to the classification of active implantable medical devices and their accessories – RANZCO recently made a submission to TGA supporting the re-classification of active implantable medical devices and their accessories in a category called Class III (Medical devices). Changing this classification would mean that active implantable medical devices (AIMD) is defined as Class III and RANZCO is therefore in agreement to re-classify AIMD and their accessories.
RANZCO submission to consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin – RANZCO recently made a submission to TGA advising of appropriate emergency eye irrigation solution use. The appropriate emergency eye irrigation solution at the time and place of chemical eye injury, usually before transfer to a healthcare facility, is tap water which of course does not require TGA classification. Should proprietary eye irrigation solutions be necessary at other times and places for chemical injury and any other indication, RANZCO believes they should remain as “Class I sterile” since they are not intended for absorption into the body, the particular feature that would require reclassification.
For more information please contact Stephanie Mulholland via email@example.com or on +61 2 9690 1001.