Does Australia require a CE mark for medical devices?
The Australian Sponsor must submit the CE Marking certificate into the eBusiness System to be reviewed. Submit a Medical Device Application into the eBusiness System and pay the application fee. The application should include: Intended Purpose Statement.
What is a Class 1 medical device in Australia?
Class 1 devices, the lowest risk medical devices, are not assessed by the regulatory body prior to inclusion on the ARTG. If the device fits into more than one classification, its proper classification is one with the highest level of risk.
How are medical devices regulated in Australia?
The TGA adopts a risk-based approach The TGA is responsible for regulating medical devices and other healthcare products such as cells and tissues, medicines, and blood products in Australia. As some medical devices pose greater risks than others we classify and regulate medical devices based on their level of risk.
Does Australia have a TGA?
The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods such as medicines, medical devices, and diagnostic tests.
Who is in charge of medical devices in Australia?
The institution that oversees medical devices in Australia is the Therapeutic Goods Administration (TGA). The TGA has established the Australian Regulatory Guidelines for Medical Devices (ARGMD), which closely resembles the regulations put into place by the European Union.
How to register your medical device in Australia?
Prepare a Clinical Evaluation Report . Select an Australian Sponsor, if you do not have a physical presence in Australia, to act on your behalf when cooperating with the TGA. Have the Technical File/Design Dossier audited by a Notified Body. Obtain your CE Marking and ISO 13485 from the Notified Body.
What do you need to know about IVD in Australia?
Manufacturers of all medical devices (including IVD medical devices) manufactured and/or supplied in Australia should ensure that they have: appropriate documentation demonstrating compliance of the device with the essential principles.
Can a medical device be CE marking in Australia?
The CE Marking will have the correct classification for your device as long as it was properly audited by a Notified Body. If there is no local/tangible presence in Australia, an Australian Sponsor must be obtained to act as an intermediary between the TGA and the manufacturer.
