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Old 12th January 2018, 04:39 PM

Total Posts: 202
Re: TGA regulations and ISO 13485:2016 gap analysis MDSAP

The QMS requirements defined in the Therapeutic Goods Regulations 2002, Schedule 3 Conformity Assessment Procedures, Part 1, are pretty basic, similar to the MDD requirements.

I have not performed a formal gap analysis, but found this information instead:

"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."


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