Apr 12, 2022

The Australian Therapeutic Goods Administration (TGA) has issued several notices recently affecting medical device manufacturers doing business in Australia. The first update clarifies TGA’s expectations for its transition to the 2021 Advertising Code. The second is updated TGA guidance on the reclassification of active implantable medical devices (AIMDs).

What are the implications of TGA’s transition to the 2021 Advertising Code?

The TGA released its guidance on Transitioning to the new Therapeutic Goods Advertising Code last week. In it, the TGA clarified its expectations for medical device manufacturers regarding the use of existing stock of hard copy advertisements following the transition to the new Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.

The agency explained how advertisers may use their existing hard copy stock of ads during the transition period currently in place until June 30, 2022. During this period, advertisers may either comply with the 2021 Code or the 2018 Code.

According to Emergo by UL sources, the TGA advises that advertisers may use the existing stock of their hard copy ads that comply with the mandatory statement requirements of the 2018 Code but are not strictly compliant with the 2021 Code. The TGA will adopt a pragmatic approach and will not seek to take enforcement action in these cases.

However, the TGA does expect advertisers to transition all ads that can readily be amended (e.g., digital ads, including social media) to the requirements of the 2021 Code by end of June 2022.

How will TGA guidance on the reclassification of AIMDs impact medical device manufacturers?

If you are a medical device manufacturer who does business in Australia, please be aware of the TGA’s update of the Reclassification of Active Implantable Medical Devices (AIMD) – Guidance on the Transitional Arrangements and Obligations, which includes details on annual reporting requirements.

The updated guidance describes when the amendments to Regulation 5.11 of the Therapeutic Goods (Medical Devices) Regulations 2002 apply to devices under the reclassification transitional procedures.

Devices that are reclassified and have not previously completed the requirement for three years of annual reporting will need to meet this requirement. Conversely, AIMDs that have already been registered for more than three years are reclassified as Class III and are excused from having to complete the three years of annual reporting a second time.

Learn more about medical device regulations and compliance in Australia from Emergo by UL:

  • Australian Therapeutic Goods Administration (TGA) registration consulting for medical device companies
  • Australia TGA Prostheses List application preparation and consulting
  • Whitepaper: Medical device registration in Australia and New Zealand

Author

  • Kathryn Burke's picture
    Kathryn Burke

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