Skip to main content

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​

A person (other than the original manufacturer of the individual components) who assembles a SOPP for supply must comply with the SOPP requirements. 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​