January 2024 Updated Guidance – System or Procedure Packs

The Therapeutic Goods Administration (TGA) has refined its guidance on system or procedure packs (SOPPs) as of January 2024. This revision builds on the foundational document released in November 2021, offering critical insights into Australia’s regulatory landscape for SOPPs. The guidance presents pathways for SOPP manufacturers, detailing how to achieve compliance and secure inclusion in the Australian Register of Therapeutic Goods (ARTG).

Manufacturers now have a clearer direction on obtaining market authorisation or pursuing a specialised assessment process for eligibility. Key to this guidance, is the stringent adherence to safety and performance standards for every device within a pack. The latest iteration of the guidance clarifies the existing framework by specifying the “Information about the SOPP Manufacturer” section. It outlines the essential documentation and evidence required from manufacturers, including ensuring mutual compatibility of components and strict adherence to manufacturing standards.

Moreover, the January 2024 update elaborates on the exemptions and exclusions from ARTG inclusion for certain packs. A notable addition is the detailed explanation under ‘Other requirements under the special conformity assessment procedure,’ highlighting labelling, usage instructions, and patient implant card information mandates, including the necessity of listing the manufacturer’s name or trade name, and address.

This update reflects the TGA’s commitment to the safe and effective supply of SOPPs in Australia, ensuring regulatory alignment with global standards. It’s an essential read for manufacturers and stakeholders in the medical devices sector, underscoring our collective aim towards maintaining the highest standards of patient care and product safety.