Medical devices conformity assessment certification for Australia
BSI is pleased to announce that, following our designation as a Conformity Assessment Body under the Mutual Recognition Agreement (MRA) between the EU and Australia, we can undertake the procedures required by the Therapeutic Goods Regulations (TGR) of Australia. This will enable clients to fast-track their products to inclusion in the Australian Register of Therapeutic Goods and hence onto the Australian market.
Conformity assessment procedures
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, BSI will issue the client with a Conformity Assessment Certificate under the EU-Australian MRA for the quality system and design examination.
Advantageous for higher risk devices
This service is available for both existing EC clients and those clients seeking an EC certification plus Australian approval, and is most advantageous for the higher risk devices. Whilst this fast track service is available only for European manufacturers, we can still help those manufacturers outside the member states by providing evidence, through assessment reports and certificates, that the Australian government can take into account.
Conformity Assessment Certificates under this MRA are valid for a period of five years after which time the certification will be reviewed. Providing everything is acceptable, the certificates will be reissued for a further five year period.
