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Medical device/medicine 'boundary' products

1 December 2005

On 21 April 2004 the TGA gazetted the Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004 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 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);
  • 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.


If you have any enquiries about these changes please contact: