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ISO 13485:2016 transition period ending

1 March 2019

The 3-year transition period for ISO 13485 (full transition to the 2016 version of the standard) ends on 1 March 2019.

In 2016 the International Organization for Standardization (ISO) published a new revision to ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes which would replace the previous version from 2003.

During a 3-year transition period, the two versions coexisted to allow users to transition to the new 2016 revision of the standard. The TGA published a notification of this transition period on our website on 9 August 2016.

Once this transition period ends, the 2016 version will be formally recognised as the only acceptable revision of this standard - the 2003 version will be made obsolete by ISO.

What does this mean for medical device manufacturers?

If you are relying on compliance with ISO 13485 to demonstrate conformity with the QMS requirements of the Australian conformity assessment procedures:

  • TGA audits

    From 1 January 2019, all TGA audits are conducted against the 2016 revision of the standard, as previously announced: Medical device quality management systems: transition to new standard

  • TGA issued ISO 13485 QMS Certificates

    All TGA issued ISO 13485:2003 QMS Certificates will expire by 1 March 2019 and cannot be extended beyond the end of the transition period.

    The TGA can only issue ISO 13485:2016 QMS Certificates to manufacturers who we have audited against the new revision of the standard.

    If you require a TGA audit to ISO13485:2016 for a new QMS Certificate, please contact us via QMS.Certificates@health.gov.au.

  • Applications for TGA Conformity Assessment

    From 1 March 2019, conformity assessment applications must be supported by evidence that a quality management system has been implemented in accordance with the 2016 revision of the standard.

    For applications lodged prior to the end of the transition period, QMS evidence based on ISO 13485:2003 will be considered as part of the application process. The TGA will advise applicants if additional QMS evidence is required to support issuing of a Conformity Assessment Certificate.

  • Manufacturers holding a current TGA issued conformity assessment certificate

    You are not required to submit any additional information to the TGA at this time if you hold:

    • a current TGA issued conformity assessment certificate for Therapeutic Goods (Medical Devices) Regulations - Part 1 excluding clause 1.6, Part 4 or Part 5, and
    • are not currently seeking TGA approval for substantial changes or re-certification, or
    • are not currently seeking a TGA issued ISO13485:2016 QMS Certificate.

Please note

Evidence of compliance with ISO 13485:2016 will be required for new recertification or substantial changes applications.

Update to Conformity Assessment Standards Order

The Conformity Assessment Standards Order (Standards for Quality Management Systems and Quality Assurance Techniques) 2008 (QMS CASO) specifies ISO 13485:2003 as the acceptable version of this standard.

This will sunset 1 April 2019, shortly after the end of the transition period. The TGA intends to release a new QMS CASO, specifying IS0 13485:2016 as the acceptable standard, before the existing instrument sunsets.

Consultation with stakeholders

The TGA will be consulting with the Regulatory and Technical Consultative Forum (RegTech) about making a new Conformity Assessment Standards Order (CASO) that will specify ISO 13485:2016 as the acceptable version of this standard, updating references to relevant sterilisation standards, and clarifying the use of the standard for demonstrating compliance with the conformity assessment procedures.

Background

In Australia, ISO 13485:2003 has been formally recognised under the Conformity Assessment Standards Order (Standards 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 manufacturer of all kinds of medical devices that require a quality management system for conformity assessment.

Quality management systems that comply with the standards specified in a Conformity Assessments Standards Order 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) Regulation 2002.

Please note

Conformity with requirements of the applicable conformity assessment standards order is not mandatory, but is one way to establish conformity with the QMS requirements of the conformity assessment procedures set out in the Regulations.

Questions

If you have any questions regarding these matters please contact devices@tga.gov.au.