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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 9.4
Conformity assessment fee — abridged assessment
- (1)
- This regulation applies in relation to an application for a conformity
assessment certificate in respect of a kind of medical device if, before the
commencement of these Regulations, the Secretary has undertaken a full
assessment of the device under the EC Mutual Recognition Agreement or the EFTA
Mutual Recognition Agreement.
- (2)
- If the Secretary considers that he or she
has sufficient information relating to the device to allow assessment of the
device under these Regulations to be abridged:
- (a)
- the Secretary may decide
to conduct an abridged assessment of the device; and
- (b)
- if the Secretary so decides, the conformity assessment fee for
consideration of the application is $2 500.
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