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Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs

Ronen E

Problem Solver
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The focus of this consultation, which follows on from an external workshop in Feb 2019, is on the proposed reforms to the regulation of systems or procedure packs and the impact of these reforms. The changes proposed in this consultation are intended to facilitate better regulatory compliance and consequently improve safety and quality of medical devices used in system or procedure packs, and will wherever possible align with the EU Framework.


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How does it aligns with FDA, Health Canada and Ministry of Japan requirements as the TGA references comparable overseas regulators? Thanks
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