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System or procedure packs
From 25 November 2021, new regulatory requirements apply to medical devices that meet the definition of 'system or procedure packs' and are supplied using the special conformity assessment procedure regulatory pathway. System or procedure packs are regulated by the Therapeutic Goods Administration (TGA) as single medical devices in their own right and therefore must be included in the Australian Register of Therapeutic Goods (ARTG).
For inclusion in the ARTG, manufacturers have two options to apply conformity assessment procedures to system or procedure packs. This relates to aspects of the manufacturing process and demonstrating that medical devices produced by it are safe and perform as intended. The manufacturer of a system or procedure pack may obtain market authorisation evidence, issued by an independent assessment body or regulator for the system or procedure pack; or use the special conformity assessment procedure set out in clause 7.5 of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the 'Regulations') if they meet the eligibility criteria for 'medical devices used for a special purpose' defined in Regulation 3.10.
The new regulations only apply to system or procedure packs that are supplied using the special conformity assessment procedure. This guidance aims to assist sponsors and manufacturers of these medical devices, by explaining their obligations under the new regulations and transitional arrangements for any of these medical devices included in the ARTG before 25 November 2021.
This guidance also describes the various regulatory mechanisms that are in place to support the supply of various types of system or procedure packs by charities and other organisations (such as schools). Refer to Appendix 1 of this guidance for more information.
- About this guidance
- Definition of 'system or procedure packs'
- Examples of SOPPs
- Systems that are SOPPs
- Procedure packs
- Classification of SOPPs
- Updated requirements for SOPPs supplied using the special conformity assessment procedure
- What are the requirements?
- Amended eligibility criteria for supply via the special conformity assessment procedure
- The special conformity assessment procedure
- Refinements to the requirements under the special conformity assessment procedure from 25 November 2021
- Other requirements under the special conformity assessment procedure
- Obligations for SOPP manufacturers
- Obligations for SOPP sponsors
- What you need to do as the SOPP sponsor
- Transition arrangements for SOPPs that are included in the ARTG or the subject of an application for inclusion made before 25 November 2021
- Applications to include SOPPs in the ARTG on or after 25 November 2021
- Appendix 1
- Products that are not medical devices or SOPPs
- Products that are medical devices but are not SOPPs that are exempt from inclusion in the ARTG
- Packs that are exempt from inclusion in the ARTG
- Packs that are excluded goods
- Questions and Answers
- Version history