Australian Meddev Regulations Updated 5 Nov 2014



The Australian medical device regulations were amended (commenced) yesterday to allow domestic manufacturers the same choice in Notified Bodies as their overseas competitors! Or as the official version states:

SLI 2014 No. 159 Regulations as made:
This regulation amends the Therapeutic Goods (Medical Devices) Regulations 2002 to allow third party conformity assessment for Australian medical device manufacturers, giving them the same capacity as overseas manufacturers to utilise private conformity assessment bodies to demonstrate conformity assessment compliance in relation to medical devices approved for supply in, or export from, Australia.
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