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Submitting a custom-made medical device / patient matched medical device transition notification GuidanceVersion 1.0, August 2022Therapeutic Goods AdministrationCopyright Commonwealth of Australia
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Identify the purpose of the regulation impact statement (RIS).
02
Gather relevant data and information to assess the potential impacts of the proposed regulation.
03
Analyze the potential costs and benefits of the proposed regulation.
04
Consult with stakeholders and experts to gather feedback and perspectives on the proposed regulation.
05
Document the findings in a clear and concise manner in the RIS.
06
Submit the completed RIS for review and approval before finalizing and implementing the proposed regulation.

Who needs regulation impact statement proposed?

01
Government agencies and policymakers who are considering implementing new regulations.
02
Stakeholders and interest groups who will be affected by the proposed regulation.
03
Economic analysts and researchers who need to assess the potential impacts of the proposed regulation.
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The regulation impact statement proposed is a document that outlines the potential effects of a new regulation on various stakeholders.
Government agencies and entities responsible for proposing the new regulation are required to file the regulation impact statement proposed.
The regulation impact statement proposed is filled out by providing detailed information on the potential impacts of the new regulation, including costs, benefits, and alternatives.
The purpose of the regulation impact statement proposed is to inform decision-makers and stakeholders about the potential effects of a new regulation before it is implemented.
The regulation impact statement proposed must include information on the costs, benefits, and potential alternatives of the new regulation.
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