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Submissions received: Alignment with European medical device regulatory framework

Up-classification of surgical mesh and Patient implant cards
Last updated

The TGA thanks respondents who provided submissions in response to the July 2017 public consultation paper Consultation: Alignment with European Medical Device Regulatory Framework.

A total of 22 submissions were received, which comprised:

  • 8 submissions from industry
  • 5 submissions from peak bodies
  • 5 consumer and consumer representative bodies
  • 2 submissions from academic institutions and hospitals
  • 2 submissions from government agencies and other respondents

All submissions that gave permission to be published on the TGA website are now available below in PDF format.

TGA response

The TGA has considered the submissions received. The feedback provided will inform the policy and future implementation pathway. Stakeholders supported TGA's proposals to up-classify all surgical mesh and to introduce consumer Product Information leaflet and patient implant cards with medical devices. There were mixed reactions to the transition times. The TGA will seek to balance the differing views and need for improved public health outcomes.

Submissions

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