Abstract
Manufacturers and suppliers, described here as sponsors, who wish to have products approved and listed for use in Australian hospitals must follow a defined process.
They must obtain an Australian Registered Therapeutic Goods number (ARTG) for the product to be used.
For benefits to be paid for prostheses used under private health insurance arrangements a catalogue number is obtained after being approved through the Prosthesis Listing Advisory Committee (PLAC). Under PLAC each group of like prostheses is assessed by a Clinical Advisory group. (Hip Prosthesis Clinical Advisory Group, Knee Prosthesis Clinical Advisory Group).
Existing criteria are being enhanced as to the levels of evidence required for listing approval.
Essentially for joint replacements which are weight-bearing and in category three a two year clinical trial will almost always be necessary for any new prosthesis. Products must bw considered as non-inferior to comparator products.
