Australia – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

Two key requirements of the conformity assessment procedures for medical devices are that a manufacturer must implement:

  • a Quality Management System (QMS) for the design, production, packaging, labelling and final inspection of a device, and
  • inspection and quality assurance techniques that are to be applied during the production of a device

The Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 specifies relevant medical device standards for quality management systems and medical devices intended to be supplied in a sterile state. The Order ensures that if a manufacturer’s QMS, or inspection and quality assurance techniques, comply with the relevant standards specified in the Order, the TGA will treat the QMS, or the inspection and quality assurance techniques, as if they comply with the parts of the conformity assessment procedures specified in the Order.

Apart from ISO13485:2016 for QMS, this order also identifies a number of other ISO standards, or parts of ISO standards, referred to in the former Order that have been updated by ISO since that order was first introduced. For example:

  • ISO 11137-2:2006 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose, has been revised by ISO 11137-2:2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose; and
  • ISO 13408-1:1998 Aseptic processing of health care products Part 1: General requirements, has been revised by ISO 13408-1:2008 Aseptic processing of health care products Part 1: General requirements…