Tag: Class I medical devices

TGA Medical Device Class I Update – Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices

What does this mean? The TGA has changed the inclusion process by which non-measuring, non-sterile Class I medical devices are included in the ARTG. The changes came into effect October 2020. What has changed? The TGA has modified the process, by which Class I inclusion applications in the ARTG are done. The application has been updated with additional requirements; applicants must now provide a manufacturer’s Declaration of Conformity when applying to include the device on the ARTG. The Manufacturer’s Declaration of Conformity form for these devices has been amended, making it more......

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