Emergo by UL offers medical device and IVD registration with the Australian TGA. Get local support for TGA approval.
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Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Australian Therapeutic Goods Administration (TGA). Emergo, with its office in Sydney, can help you register your medical device or IVD with the TGA so you can start exporting your products into the Australian market.
Companies that have already acquired market access in Europe will find the Australian TGA regulatory approval process much easier because the TGA recognizes other comparable regulatory agency’s market authorizations (including the EU CE marking certificate ). In fact, most foreign companies seeking market access in Australia already have CE marking or FDA clearance. However, even if the medical or IVD device has authorization in a reference market, it must still be registered with the TGA and receive an ARTG listing number. There is also a mandatory audit for certain device classifications.
The TGA uses a four-tiered classification system based on risk to the human body, with ascending risk assigned to Classes I (including sterile and measuring), IIa, IIb and III, respectively. Like most systems, regulatory control increases with increasing risk level. Australian classification rules are almost identical to the EU classification criteria, and classification in Australia will generally reflect that of the EU. Note that there are certain exceptions, and differences in classification may limit the ability to leverage their EU CE marking certificate or trigger a mandatory application audit of the ARTG application. Thus, classification should always be confirmed according to Australian classification rules. Emergo can assist with confirming the classification of your medical and IVD devices.
