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  • Regulatory NewsRegulatory News

    TGA Unveils Guidance on the Regulation of SaMD, Personalized Medical Devices

    Australia’s Therapeutic Good Administration (TGA) released further guidance Wednesday on the regulation of software, including software as a medical device (SaMD), and a separate new guidance to propose a regulatory framework for personalized devices, including 3D-printed devices. The 19-page SaMD document expands on guidance TGA posted last December. The 23-page proposed regulatory scheme for personalized medical devices comes after the agency launched a consultati...
  • Regulatory NewsRegulatory News

    Health Canada Drafts Policies on 3D-Printed Implantable Devices

    Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing.   The guidance “represents the first phase of 3D-printing policy in Canada” because Health Canada intends to continuously adapt its policies to emerging issues on the topic “due to the fast-changing technological environment,” the regulator said.   3D-printed medical devices may be s...
  • Regulatory NewsRegulatory News

    TGA Weighs Changes to Regulations for Personalized, 3D Printed Devices

    Australia's Therapeutic Goods Administration (TGA) on Thursday launched a consultation on proposed changes to the country's medical device regulations for personalized and 3D printed medical devices. According to TGA, the Australia's current regulations, which include exemptions from registration for custom-made devices, have not kept up with the pace of innovation in the custom device space. "The provisions were based on the premise that affected devices would largely ...