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International Partners


CMDCAS Health Canada

In Canada, regulations require that certain medical devices be designed and manufactured under a registered quality management system (QMS) that meets the criteria of the international standard ISO 13485:2003
 
NSAI is accredited and qualified by Standards Council Canada (SCC) to perform assessment and certification of your medical device quality system to the internationally recognized quality standard ISO 13485:2003: Medical Devices, Quality Management Systems – Requirements for Regulatory Purposes.

Australia

NSAI is designated as a Conformity Assessment Body under the Mutual Recognition Agreement (MRA) between the EU and Australia to undertake the procedures required by the Therapeutic Goods Regulations (TGR) of Australia. 

This allows medical device clients to have their products included in the Australian Register of Therapeutic Goods and hence onto the Australian market.

Tel:       + 353 1 8073929
Fax:      +353 1 8073996
E-Mail: medical.devices@nsai.ie




Last Updated - [29 Oct 2008 @ 15:21:39]

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