Department of Therapeutic Goods Minor or machinery: These amendments are If the way the fees and charges are Health to increase fees and calculated using a well-established formula. amended changes, that may require a charges for therapeutic goods and RIS. manufacturing licences Department of Therapeutic Goods Minor: These amendments are not regulatory Health standards in relation to in nature, since they are made to voluntary medical devices standards that can be used by stakeholders if they choose. There is no expectation of compliance.
Department of Health Therapeutic Goods to increase fees and charges for therapeutic goods and manufacturing licences Minor or machinery: These amendments are calculated using a well-established formula. If the way the fees and charges are amended changes, that may require a RIS. Department of Health Therapeutic Goods standards in relation to medical devices Minor: These amendments are not regulatory in nature, since they are made to voluntary standards that can be used by stakeholders if they choose. There is no expectation of compliance.
carve-out-guidance-note_0.docx