Jul 12, 2022

Australia’s Therapeutic Goods Administration has issued a number of new pieces of guidance that medical device manufacturers doing business in the country should review to make sure they maintain compliance. First, the TGA has updated two guidance documents related to the reclassification of certain implantable medical devices. Second, the regulator ruled on requirements for its six-monthly reporting process.

Updated guidance on the reclassification of implantable medical devices

The TGA has updated two guidance documents related to the reclassification of certain implantable medical devices, which took effect on November 25, 2021.

The Reclassification of Active Implantable Medical Devices (AIMD) was updated to include instructions for submitting a reclassification application, including cases where the Global Medical Device Nomenclature (GMDN) code has been updated or made obsolete.

The updated Reclassification of Spinal Implantable Medical Devices notes the removal of the temporary Class IIb Product Name Variation Form from the TGA Business Services (TBS) system portal. It was previously required that manufacturers of Class IIb spinal fusion devices notify the TGA before November 25, 2021 and add the product names to the Australian Register of Therapeutic Goods (ARTG) entry. Now, under the revised procedure, manufacturers should submit a Device Change Request (DCR) to amend, remove or add product names.

Guidance on Six-Monthly Report for devices supplied under SAS and AP schemes

The TGA has published the guidance Six Monthly Report - Supply of Unapproved Therapeutic Goods (A Step-By-Step Guide to Completing the Form), which provides an overview of the required six-monthly reporting process for therapeutic goods supplied under the Special Access Scheme (SAS) and Authorized Prescriber (AP) scheme.

Sponsors or manufacturers of these therapeutic goods must submit the report using the Six Monthly Report - Supply of Unapproved Therapeutic Goods by a Sponsor form. This form must be submitted within one month following the end of the relevant reporting period, either from January 1 to June 30, or July 1 to December 31.

Learn more about medical device regulations and compliance in Australia from Emergo by UL:

  • Australia TGA regulatory approval process for medical devices chart
  • Australian Therapeutic Goods Administration (TGA) registration consulting for medical device companies
  • Whitepaper: Medical device registration in Australia and New Zealand

Author

  • Kathryn Burke's picture
    Kathryn Burke

Related