Regulation of medical device/medicine "boundary" products
On 21 April 2004 the TGA gazetted the Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004 <http://www.tga.gov.au/legis/tgdev0401.htm> under Section 41BD(3) of the Therapeutic Goods Act 1989. Implementing the following changes to the way the TGA regulates antiseptic wipes, irrigation solutions, haemodialysis solutions and IVF media.
The Australian Medical Devices Guidance Document No. 35 Device-medicine boundary products <http://www.tga.gov.au/docs/html/devguid35.htm> also provides information on the status of boundary products for ARTG purposes.
Products that will now be regulated as medicines:
- Antiseptic wipes for use on human skin (see Regulation of alcohol wipes - November 2005 <http://www.tga.gov.au/devices/alchololwipes.htm>);
- Paper tissue with antiseptic and/or viricide for use on human skin.
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.
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 4 October 2007 to meet the new requirements. However, new applications for entry onto the ARTG for the above mentioned products will now have to meet the new requirements.
Enquiries
If you have any enquiries about these changes please contact:
- OTC Medicines on phone: 02 6232 8670 or email: OTC.Medicines@tga.gov.au in regard to antiseptic products that will be regulated as medicines
- Office of Devices, Blood & Tissues on phone: 02 6232 8793 or email: CAB.medical.devices.information@tga.gov.au in regard to products that will be regulated as medical devices