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tga [2026/08/12 08:47] – [Potentially illegal use] gary1tga [2026/08/12 08:51] (current) – [Classification of TGA approved medical devices] gary1
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 =====Classification of TGA approved medical devices===== =====Classification of TGA approved medical devices=====
-  *All devices must comply with six general "Essential Principles" - a further nine Essential Principles relating to design and construction apply to devices on a case-by-case basis+  *All devices must comply with six general **[[https://www.tga.gov.au/resources/guidance/complying-essential-principles-safety-and-performance-medical-devices|"Essential Principles"]]** - a further nine Essential Principles relating to design and construction apply to devices on a case-by-case basis
     * after a device is approved, the manufacturer must:      * after a device is approved, the manufacturer must: 
       * continue to monitor the performance and safety of their device, and,       * continue to monitor the performance and safety of their device, and,
tga.txt · Last modified: 2026/08/12 08:51 by gary1

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