TGA Post-Market Responsibilities for Medical Device Sponsors and Manufacturers

1. Overview and Purpose

The Therapeutic Goods Administration (TGA) provides guidance on post-market responsibilities for sponsors and manufacturers of medical devices supplied in Australia. These obligations ensure devices continue to meet safety, quality, and performance standards after inclusion in the Australian Register of Therapeutic Goods (ARTG). Systematic monitoring, investigation, and reporting of safety issues protect public health. Post-market data may lead to corrective actions, recalls, or regulatory changes. Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

2. Relevant Legislation

Key laws include:

• Therapeutic Goods Regulations 1990
• Therapeutic Goods (Medical Devices) Regulations 2002
• Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument (No. 4) 2021 Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

3. Sponsor Responsibilities

Sponsors link manufacturers to the TGA and ensure supplied devices meet requirements. They collaborate on decisions affecting Australian devices.

Key obligations:

• Comply with conditions of inclusion (automatic and additional)
• Report adverse events via IRIS
• Undertake recalls/non-recall actions per URPTG
• Notify TGA of lapsed conformity assessment certificates
• Ensure advertising compliance
• Report counterfeit/tampered devices
• Pay annual charges
• Maintain up-to-date contacts Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

Non-compliance may result in ARTG suspension/cancellation or penalties.

4. Conditions of Inclusion

• Additional COIs: Require reports on safety/performance; imposed at inclusion or later; sponsors submit manufacturer reports on time.
• Automatic COIs: Apply to all entries, including inspections, sample delivery, documentation access, incident reporting, and distribution records. High-risk devices require annual reports for three years. Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

5. Adverse Event Reporting

Sponsors report all Australian adverse events via IRIS (mandatory under regulations). Manufacturers investigate; sponsors facilitate. Reporting does not imply liability. Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

6. Recalls and Corrective Actions

Follow URPTG for recalls due to safety/quality issues. Sponsors notify TGA and obtain agreement before actions. Report overseas regulatory actions affecting Australian supplies. Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

7. Advertising Compliance

All advertising must comply with the Therapeutic Goods Advertising Code. Sponsors ensure suppliers/retailers follow rules; restricted representations require TGA approval. Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

8. Manufacturer Responsibilities

Manufacturers maintain conformity assessment evidence, comply with Essential Principles, review post-market data, and notify changes. Records kept for 5-10 years depending on class. Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

9. Distribution Records

Maintain import/export/supply records (including batch numbers, dates, recipients) for specified periods (5-10 years by class). Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices

10. Other Duties

Collaborate on post-market reviews, report counterfeits, and handle certificate changes. Source: https://www.tga.gov.au/resources/guidance/understanding-your-post-market-responsibilities-medical-devices