TGA releases new Uniform Recall Procedure

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A new Uniform Recall Procedure for Therapeutic Goods 2017 (URPTG) (V2.0, October 2017) has been released for a 'familiarisation period', with the revision due to come into effect on Monday 15 January 2018.

The TGA has advised that the notice period provides stakeholders with about three months to familiarise themselves with the document and implement appropriate internal procedures. Sponsors will be asked to follow the new procedure from this date and the current version will then be archived.

The new URPTG can be found online.

Medical Devices Sponsor Information Day

Members are advised there is still time to register for next week’s 2017 Medical Devices Sponsor Information Day, to be held on 11 October 2017.

The Day will be held in Canberra, jointly organised (and supported) by the TGA, AusBiotech, Medical Technology Association of Australia, Australian Dental Industry Association, IVD Australia, and the Australian Medical Manufacturers & Distributors Association.

The day is designed to provide you with a better understanding of the regulatory framework for medical devices, in-vitro diagnostic devices (IVDs), and other therapeutic goods, including your roles and responsibilities with respect to:

  • Including these on the Australian Register of Therapeutic Goods, and
  • Maintaining your inclusions/managing your post-market responsibilities.

Information on the day will be jointly presented by members of the TGA and the medical device industry, which is designed to give participants an appreciation of both perspectives. Each presentation will have a set of slides that will be made available through the TGA's website after the event.

The event is a focused, single-day program and is one of the best opportunities of the year for sponsors to hear directly from TGA officials and industry experts on the workings of Australian regulations.

For the full program, venue details and registration visit the Sponsor Day Website.