Making excellence a habit
The 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.
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.
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:
Depending on the manufacturer, there are a few ways we can assist in the certification process:
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: