TGA Releases New Regulations on Personalized Medical Devices

Australia’s Therapeutic Goods Administration (TGA) has released new regulatory requirements for personalized medical devices that will become effective Feb. 25, 2021.

The TGA said that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate the risks to patients.

Of particular concern are regulatory considerations for devices made for particular patients, which are covered under the TGA’s current custom-made definition that exempts the products from regulatory requirements, such as inspections and third-party certifications.