Requirements for the assessment of medical devices containing animal material

Related information

  • Transmissible Spongiform Encephalopathies (TSEs)

Australian medical devices guidelines

4 August 2003

Guidance document number 14, Version 1.6

This guidance document is one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that commenced on 4 October 2002. The new system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002.

This guidance document applies to:

  • medical devices incorporating tissues, their derivatives or other substances originating from animals for which there is a risk of transmission of TSEs under normal conditions of use, to either the patient or user; and
  • materials derived from tissues, their derivatives or other substances originating from animals for which there is a risk of transmission of TSEs, that are used or come into contact with the medical device during its manufacture.

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Contents

  • Introduction
  • Definition of "Animal"
  • The basic approach to minimising risks of transmitting TSEs
  • Medical devices falling into Class III under Schedule 2, Part 5.5 of the Therapeutic Goods (Medical Devices) Regulations 2002
  • Implications for lodging applications for inclusion in the Australian Register of Therapeutic Goods for medical devices not classified as Class III under Rule 5.5
  • The risk assessment process
  • Annex A (Tallow and Tallow Derivatives, Bone Derived Gelatin and Collagen)
  • Annex B (Risk analysis and risk management)

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