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.
MoreWe collect your browsing history through cookies to understand how you use our website to analyze and improve your experience. By continuing to use our website, you accept our use of cookies.
