A recent announcement by the Therapeutic Goods Administration Australia (TGA) provides information for current users of ISO 13485:2003 who are considering transitioning to ISO 13485:2016, and other interested parties.
This announcement comes on the heels of the publication of a new revision to ISO 13485, the medical device quality management systems (QMS) standard for regulatory purposes, which replaces the previous version from 2003 by the International Organization for Standardization (ISO). It is already confirmed that the ISO 13485:2003 and ISO 13485:2016 will coexist for the next three years so as to allow users of the standard to transition to the new revised standard. It is recommended that the users of ISO 13485:2003 work with the TGA, or their EU Notified Body, CMDCAS Registrar, MDSAP Auditing Organisation, or other recognised certification body, to schedule an upgrade audit at a convenient time within the transition period.
To add on, ISO 13485:2003 is now formally recognised in Australia under the Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008, made for the purposes of section 41DC of the Therapeutic Goods Act 1989, as a standard for the manufacture of all kinds of medical devices that require a quality management system for conformity assessment.
In the interim, the TGA will continue to recognise audits based on ISO13485:2003 for the period indicated on the associated certificate, however these certificates must expire no later than 1 January 2019 (aligning closely with the end of the ISO transition period on 1 March 2019).
Additionally, audits based on ISO13485:2003 will continue to be conducted by the TGA until 1 January 2019 unless the manufacturer elects to use the newer standard. Audits performed by the TGA under the EU-AU Mutual Recognition Agreement (MRA), as a Conformity Assessment Body, will be carried out against EN ISO13485:2012 or EN ISO13485:2016 as required by the EU Commission.