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Magnets and Magnetic Energy Theory, Products, Saftey and the Real Facts Very Important Notice To all Manufacturers, Sponsors, Importers and Exporters of Medical and Therapy DEVICES. Urgent notification to all who are not aware of the changes to the new TGA Regulations (October 2002), with updates authorised by TGA Devices officers late 31 May 2004. The regulatory scene for devices has changed in Australia. The Therapeutic Goods Administration (TGA) administers the regulatory requirements in Australia. Regardless of the large number of devices that were Excluded by the "Excluded Goods Order No.1 & 2 of 1998", and were then "not subject to the controls of the Therapeutic Goods Act" the revised legislation as announced in October 2002 now means that all devices with any health related claims or uses whatsoever must comply with the new legislation. For those products that were being supplied and on the Australian Register of Therapeutic Goods (ARTG) before 4 October 2002 and have been paying the annual renewal fees, the manufacturers and sponsors of such devices have until 4th October 2007 to meet all the requirements, where applicable, such as:
In practice this will mean:
Where devices were not entered on the ARTG by the 4th of October 2004, or have not successfully been entered it is now too late and not legal to supply. If your devices are not currently on the ARTG, or are "Excluded" or "Exempt", then you MUST visit the relevant TGA Web site: www.tga.gov.au/devices/devices.htm and particularly www.tga.gov.au/docs/pdf/meddevreg.pdf and browse through each section, article and link. This will give you an insight into the required steps necessary to become compliant under the new regulatory system. For clarification it is also strongly recommended to contact an information officer at the TGA on Freecall: 1800 141 144, or by Fax on: (02) 6232 8299, or Email: medical.device.information@health.gov.au and enter your questions requesting an Email reply. Enquiries by mail can be sent to: TGA, PO Box 100, Woden, ACT 2606 If your devices are not currently on the ARTG, or are not in the application process for entry on the ARTG you will not be able to legally supply such devices from 5 October 2004. These details have deliberately been repeated in this letter to reinforce the urgency of this matter. Earlier in 2004, the TGA were conducting a series of education seminars around the major cities on the ‘medical devices regulatory system’ for all sponsors and manufacturers, including those whose products were previously Exempt/Excluded and Class 1 devices. ACONT Devices Council is here to help you in understanding the necessity to be compliant. SOME FURTHER & REPEATED INFORMATION: To all Medical/Therapy &/or Test Device sponsors, This is an update urgent memo letter to advise the many sponsors, manufacturers, suppliers, of devices that now come under the new regulations in force since 4 October 2002, and which allowed for a two year period for all devices to come into compliance. If your products were not on the ARTG (Australian Register of Therapeutic Goods) before 4 October 2002 the regulations made it clear that there was only a two year period to make application and to be in compliance. From 5 October 2004 it is not legal to supply any products that come under the revised criteria of a Therapeutic or a Medical Device. "Supply of a Medical Device that is not entered on the ARTG, or that does not comply with the requirements of the Therapeutic Goods Act and Regulations can incur severe penalties up to $550,000.00 or 12 months imprisonment, or both." Involved in devices? If you manufacture, import, export, or supply medical/therapeutic products that are not medicines, and - IF YOU THINK IT DOESN'T INVOLVE YOU, WELL, THINK AGAIN !!... BECAUSE IT DOES! Please ensure that you understand the implications and responsibilities of all sponsors. Visit the TGA Website as provided, and browse carefully through all the headings and all the links. There is a lot of information and a lot of links that must be checked out, so give yourself a few hours to check what is applicable to your operation, and plenty of paper for the sections that should be printed out and saved in your regulatory filing system. |
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Privacy & Copyright © Australian Committee Of Natural Therapies Inc 2004 ABN 80 132 203 097 Last Updated 1st October 2004 |