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.
ISO standards are often adopted by regional or national standards organisations. Where a regionally or nationally adopted version of an ISO standard has been applied and the adopted version of the standard is identical to the original parent publication of the ISO standard, the TGA treats these standards as being interchangeable with the original parent ISO standard.
For example, the standard ISO 13485:2016 - Medical Devices - Quality management Systems- Requirements for regulatory purposes has been adopted as an identical regional or national standard in several jurisdictions:
EN ISO 13485:2016 (also I.S. EN ISO, DIN EN ISO, BS EN ISO, NSAI ISO etc.) in Europe,
ANSI/AAMI/ISO 13485:2016 in the USA, and
AS ISO13485:2017 in Australia.
While the Order only specifies the parent ISO 13485:2016 standard, where a manufacturer has met the requirements of an identical regional/national adopted standard the TGA considers that the requirements of ISO 13485:2016 have also been met.
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