CE-Mark Acceptance Outside the EU
Australia
By September 1, 2000 new legislation to regulate medical
devices should be implemented. The Australian Government
has given the go ahead for the drafting of a bill that
harmonizes Australia's medical device regulations with
that of the European Union. With one exception, the
Therapeutic Goods Administration (TGA) will continue to
be the only organization performing pre-market and post-
market surveillance.
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