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Systems and Procedure Packs

Overview​

A system or procedure pack (SOPP) is a combination of products — which may include medical devices, medicines, and other items — packaged together by a person other than the original manufacturer for use in a specific medical procedure. SOPPs have their own regulatory requirements under Section 41BF of the Therapeutic Goods Act 1989 and were subject to definitional changes in 2020.

Classification​

The classification of a SOPP is determined by the highest classified component it contains. For example:

  • A SOPP containing a Class IIb device and Class IIa devices → classified as Class IIb
  • The presence of a medicine in a pack does not affect the classification
  • Both IVD and non-IVD SOPPs are possible; where a SOPP contains both IVD and non-IVD components at the same classification level, specific rules apply

Who Can Assemble a SOPP​

Any person (including hospitals and healthcare facilities) who assembles a SOPP for supply becomes the manufacturer of that SOPP for regulatory purposes and must comply with all SOPP requirements, even if the individual components were manufactured by others. The assembler is responsible for compliance with all SOPP-specific obligations. This includes hospitals that assemble custom procedure kits and companies that repackage individual devices into kits.

Key Requirements for SOPP Assemblers​

  • Ensure all devices in the pack are included in the ARTG (or otherwise authorised for supply)
  • Prepare a Declaration of Conformity for the SOPP
  • Apply a SOPP label that clearly identifies all components
  • Include instructions for use if the combination creates additional risks not covered by individual component IFUs
  • Obtain a separate ARTG entry for the SOPP

Official Sources​