Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Reach the Australian medical device market with a single QMS audit.
The Australian medical device market is a significant opportunity for foreign manufacturers: it's a $3 billion market with more than 36,000 devices listed, of which about 95% are imported. The Australian market is quick to adopt new products that will improve patient outcomes and decrease healthcare costs.
If you're a medical device manufacturer based in Canada, you can reach this promising market by taking advantage of a new memorandum of understanding (MOU) between Health Canada and the Therapeutic Goods Administration (TGA) of Australia. Under the MOU, the TGA will accept ISO 13485 certificates issued by select Health Canada-recognized (CMDCAS) registrars to eligible Canadian medical device manufacturers exporting to Australia.
Intertek is the first certification body to be recognized under the MOU. By having a local Intertek auditor complete a single quality management system (QMS) audit that covers Canadian, Australian, and other regulatory requirements, you can reduce operational disruptions, lower audit costs, and save valuable time. You'll also benefit from Intertek's deep expertise, industry-leading turnaround times, and business-focused audit philosophy.
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