Medical device quality management systems: transition to new standard

9 August 2016

This information is intended for current users of ISO 13485:2003 who are considering transitioning to ISO 13485:2016, and other interested parties.

In March of this year the International Organization for Standardization (ISO) published a new revision to ISO 13485, the medical device quality management systems (QMS) standard for regulatory purposes, which replaces the previous version from 2003. Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing for users of the standard to transition to the new revision of the 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.

In Australia, ISO 13485:2003 is formally recognised 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.

Quality management systems that comply with the ISO13485:2003 standard are treated as complying with the relevant parts of the conformity assessment procedures for Quality Management Systems set out in the Therapeutic Goods (Medical Devices) Regulations 2002.

Prior to the end of the transition period the TGA anticipates to update the relevant Conformity Assessment Standards order to reference the newer ISO13485:2016.

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).

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.

The TGA is an active participant in the Medical Devices Single Audit Program (MDSAP). The other participating agencies are the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, the Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), and the United States of America Food and Drug Administration (FDA). Manufacturers who are seeking to meet the Quality Management System requirements of th participating jurisdictions are encouraged to contact a participating MDSAP Pilot Eligible Auditing Organisation to discuss how they may assist with the audits required under this program. MDSAP Auditing Organisations are required to conduct all audits for the MDSAP in accordance with ISO 13485:2016 by the end of the ISO transition period. Individual Auditing Organisations are establishing their own transition timelines to ensure that all clients have transitioned by 1 January 2019.

Health Canada announced in January 2016 that the current CMDCAS program will transition to MDSAP between 1 January 2017 to 31 December 2018. The TGA is not seeking to become a recognised MDSAP Auditing Organisation and will therefore exit the arrangements under the Health Products and Food Branch (HPFB)/TGA MoU on Quality Management System certification for medical device manufacturers from 1 January, 2019. Any audits conducted by the TGA for QMS certification for Canada during the transition period will be performed using ISO13485:2003 unless the manufacturer requests that compliance with the newer standard be verified at an earlier date.