This guidance document describes the requirements and notification process for the applicant to get approval from the Authority prior to the importation and/or market placement of custom-made medical devices.
More TGA has introduced a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG) if they are being supplied in volumes of more than five per financial year.
MoreWir verwenden Cookies, um Ihnen ein optimales Website-Erlebnis zu bieten und um die Zugriffe auf unserer Internetseite analysieren zu können. Klicken Sie auf "Ich stimme zu", um Cookies zu akzeptieren und direkt zur Website weiter zu navigieren.
