Australian market access

Therapeutic Goods Regulations (TGR) of Australia

Australia market accessThe Therapeutic Goods Regulations (TGR) of Australia defines the country’s requirements for medical device certification. And in order to achieve TGR certification, medical device manufacturers must undergo conformity assessments performed by a recognized body such as BSI. The Australian Therapeutic Goods Administration (TGA) also recognizes European CE marking, so some manufacturers will already be closer to achieving compliance for entering the Australian market.

TGA conformity assessment certificate procedures

Accredited by the Mutual Recognition Agreement (MRA) between the EU and Australia, BSI is designated as a Conformity Assessment Body and is fully equipped to help your company achieve compliance with TGR, fast tracking products to the Australian market.

This service includes a review of the client's documentation demonstrating compliance to the TGR Essential Principles (similar to the European Essential Requirements) and the Conformity Assessment Procedures as laid out in Schedule 3, Part 1 of the TGR (similar to the EU Conformity Assessment Procedures).

Following successful completion of the review, we will issue the client with a Conformity Assessment Certificate under the EU-Australian MRA for the quality system and design examination.

How can BSI help you obtain a conformity assessment certificate?

Our team of experts has extensive conformity assessment experience in the EU and other global markets, and we are committed to acting as your partner during the review process. Any challenges during conformity assessment are faced with one goal in mind: getting your product to market efficiently. An overview of the process consists of:

  • BSI conducts a comprehensive review of your documentation, ensuring device(s) demonstrate compliance with TGR Essential Principles (similar to the European Essential Requirements) and TGR Conformity Assessment Procedures (also similar to EU standards)
  • Following successful completion of the review, BSI will issue a Conformity Assessment Certificate (under the EU-Australian MRA) for the device’s quality system and design examination
  • Conformity Assessment Certificates under this MRA are valid for a period of five years after which time the certification will be reviewed. With a compliant follow-up review, the certificates will be reissued for another five-year period

Depending on the manufacturer, there are a few ways we can assist in the certification process:

  • For existing EC clients, our conformity assessments will help you achieve TGR compliance quickly and efficiently
  • For clients seeking EC certification plus Australian approval, we can provide conformity assessments that help you achieve market readiness in both the EU and Australia
  • For countries outside the EU member states, we cannot offer conformity assessments for TGR compliance, but we can provide evidence (through assessment reports and certificates) that the Australian government can consider in their evaluations

Partnering with us in the conformity assessment process is especially beneficial for manufacturers taking high-risk devices into the Australian market.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: