Medical Device Registration in Australia Process:
Therapeutic Goods Administration (TGA) oversees regulation of medical devices in Australia through Australian Regulatory Guidelines for Medical Devices (ARGMD) and these guidelines closely resemble with the regulations put into place by the European Union. To gain access to the Australian market, medical device and IVD manufacturers need to include their products in the Australian Register of Therapeutic Goods (ARTG). Medical devices are obliged to be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia, imported into Australia or exported from Australia. currently TGA recognises CE marking, means companies who have already acquired the European market can easily meet TGA requirement.
Classification of Medical Devices in Australia
In Australia, medical devices are classified as per the Australian Therapeutic Goods (Medical Devices) Regulations 2002. Medical devices are classified with respect to their intended purpose. Particularly, the classification rules take into consideration the degree of invasiveness in the human body, the duration use, location of use, and whether the device relies on a source of energy other than the body or gravity.
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