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Australia MRA - Australian Medical Devices Regulations

SGS is an approved medical devices certification body under the Mutual Recognition Agreement with Australia (MRA). Only a few Notified Bodies such as SGS have been approved by the Therapeutic Goods Administration (TGA) under this MRA for the Australian medical devices regulations.

The Australian Therapeutic Goods (Medical Devices) Regulations 2002 are, in many ways, similar to the equivalent EC directive. Low risk devices can be registered and sold on the basis of our CE marking certification. Higher risk devices require specific documentation assessment by SGS in our capacity as a TGA approved conformity assessment body.

Although our CE mark certification and United Kingdom Accreditation Service (UKAS) accredited ISO 13485:2003 certification will assist the approval of all medical devices in Australia, only manufacturers situated in Europe can be offered certification directly under the MRA.

SGS is your ideal certification partner for Australia MRA certification, allowing you to sell your medical devices in Australia often with no extra assessment. It is expected that a future change in regulations will give manufacturers who use MRA approved certification bodies even more advantages.

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