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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 4.3
Time for making decision on applications (Act s 41ED, s 63 (2) (dc))
- (1)
- This regulation applies to an application for the issue of a conformity
assessment certificate in respect of a kind of medical device if, in
considering the application, the Secretary is required to examine the design
of the device.
- (2)
- The Secretary must make a decision on the application
within 255 working days after the application is received at an office of the
Department specified by the Secretary.
- (3)
- For subregulation (2), a working day that occurs in any of the following
periods is to be disregarded:
- (a)
- if the Secretary sends a query, or a
request for information, to the applicant or sponsor — the period
beginning on the day when the query or request is sent and ending at the end
of the day when the Secretary receives from the applicant or sponsor a
response that enables the Secretary to proceed with the assessment;
- (b)
- if an appeal is lodged in relation to the application — the
period beginning on the day when the appeal is lodged and ending at the end of
the day when the appeal is finally determined;
- (c)
- any other period in relation to which the applicant or sponsor agrees in
writing for the purposes of this subregulation.
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