Requirements for the assessment of medical devices containing animal material

Guidance document number 14, Version 1.6

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.

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)