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Regulation of medical device/medicine 'boundary' products
Letter to stakeholders
The following letter was sent to stakeholders in December 2003. It remains on this website as a historical reference.
Regulation of Medical Device/Medicine "Boundary" Products
Further to the consultation that took place in March and June 2003, I am writing to advise you of changes to the way the TGA regulates antiseptic wipes, irrigation solutions, haemodialysis solutions and IVF media.
On 4 October 2002 the new system for the regulation of medical devices in Australia commenced. As with the previous regulatory system, there are a number of "boundary" products which can be considered to be either medicines or medical devices depending on the way the manufacturer markets the principal intended action. The TGA has reviewed the classification of these products and is implementing changes to bring the Australian system into line, as far as practicable, with internationally recognised distinctions that align with the European Union (EU) system.
To implement the changes the TGA will gazette the Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004 under Section 41BD(3) of the Therapeutic Goods Act 1989.
Products that will now be regulated as medicines:
- Antiseptic wipes for use on human skin;
- Paper tissue with antiseptic and/or viricide for use on human skin.
Most products will need to be 'registered' in the Australian Register of Therapeutic Goods (ARTG). Sponsors of these products will need to apply for registration of the above products according to the requirements in the Australian Guidelines for the Registration of Drugs, Volume 2 (AGRD2)*. Information on the registration process and a copy of the guidelines can be found on the TGA web site.
*Note: the AGRD2 was replaced replaced by the ARGOM on 1 July 2003
Some products will need to be 'listed' in the ARTG (e.g. those containing herbal active ingredients).
In recognition of the changed nature of the technical and administrative documentation required for ARTG entry, sponsors of products that are already on the ARTG will be given until October 2007 to meet the new requirements. However, new applications for entry onto the ARTG for the above mentioned products will have to meet the new requirements from the date the Section 41BD(3) Order is gazetted.
Products that will now be regulated as medical devices:
- Irrigation fluids (saline and sterile water) that are not intended for intravenous use;
- Ear irrigation liquids;
- Lubricants with spermicide or viricide;
- Haemodialysis dialysates; and
- IVF cleavage medium, blastocyst medium and fertilisation medium.
The products listed above fit within the definition of a medical device. Therefore, no regulatory amendment is required and the TGA has commenced accepting applications for ARTG 'inclusion' as a medical device for these products. Sponsors of products that are already on the ARTG as listed or registered medicines will have until October 2007 to have these products included as medical devices. Further information on the legislative requirements for medical devices is at: Australian medical devices guidelines: 1. An overview of the new medical devices regulatory system.
The TGA is willing to meet with sponsors to discuss how the new requirements can be met. To assist stakeholders in deciding which boundary products are regulated as medicines and which are regulated as devices the TGA is currently updating the Device & Drug Distinctions, August 1998 document. Once updated the document will be located on the TGA web site under What's New. Advice that the Section 41BD(3) Order has been gazetted will also be placed under What's New on the TGA website.
Office of Devices, Blood and Tissues
22 December 2003