Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

Other considerations

 Regulator overload ● E.g Malaysia

● Proprietary Information ● E.g quantities of materials use range or note that this is proprietary.  Regulatory Information ● Changes can happen quickly!

The Organisation for Professionals in Regulatory Affairs

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Sources of Information

 Regulator websites ● FDA, HC, TGA  Consultants ● Emergo ● Arazy ● Pacific Bridge Medical

The Organisation for Professionals in Regulatory Affairs

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