ISO 13485 Certification for the Health Canada TGA MOU

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. 

Need help or have a question? +61 1300 046 837

Need help or have a question?

+61 1300 046 837
+44 (0) 116 296 1620
+1 800 810 1195
+46 8 750 03 33
Asia Pacific
+86 21 50273066