Published 31 July 2017 by Francesca Trimboli

TGA seeking comments about reclassification of implantable mesh products

The TGA is seeking comments on two measures to further align Australian and European medical device regulatory requirements:

  • Reclassification of all implantable surgical mesh medical devices from a Class IIb (medium to high risk) to Class III (high risk); and
  • Introduction of formal requirements for medical device manufacturers to provide patient implant cards and product information for all active and implantable medical devices.

The TGA is looking for views from industry, healthcare professionals, and current (and future) recipients of medical devices on the proposed implementation approach for these changes. Comments will assist the TGA to identify issues, and address any unintended consequences, to inform the proposals and the regulatory amendment process.

Health Issues Centre is delighted to see that the TGA is considering the reclassification of all implantable mesh products, and ensuring that patients have access to accurate information about the benefits and risks so that people can make an informed decision.

The 11 page proposal outlines some of the ideas about what could happen. This is an opportunity to provide your thougths about these ideas. Is it enough? What else can be done to ensure that the system is protecting people and supporting them to access quality information so that they can make an informed decision.

Have your say before August 25 2017. https://www.tga.gov.au/consultation/consultation-alignment-european-medical-device-regulatory-framework

Published 31 July 2017 by Francesca Trimboli

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