Jul 1, 2019

The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device Standards Order (MDSO), Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, on June 19, 2019.

The guidance explains changes to the order that were implemented earlier in 2019. The changes include the addition of ISO 13485:2016 as a recognized standard for medical device quality management systems (QMS) and updated sterilization standards.

TGA now recognizes ISO 13485:2016 and identical regional standards

The revised order allows medical device manufacturers seeking regulatory approval in Australia to leverage ISO 13485:2016 certification for quality management system conformity. According to the guidance, TGA will recognize quality management systems, and/or inspection and quality assurance techniques, that comply with ISO 13485:2016 “as if they comply with conformity assessment procedures specified in the order.”

TGA will also recognize identical standards in jurisdictions where ISO 13485:2016 has been adopted, including Europe, Australia, and the US.

Updated standards for medical device sterilization

Manufacturers of devices supplied sterile can meet device processing and quality assurance requirements through adherence to recognized ISO standards listed in this document. The list of conformity assessment standards in this document reflects current versions or parts of standards released since the last order was published.

Sterilization standards were previously specified in a separate order, Medical Device Standards Order (Standards for Medical Devices Required to be Sterile) 2008, which is no longer in force.

Learn more about Australia TGA medical device regulations at Emergo by UL:

  • Australia TGA consulting for medical device and IVD companies
  • ISO 13485:2016 quality management system consulting
  • Regulatory process chart: Australia TGA medical device registration requirements