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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 8.1
Notice period (Act s 41JA)
For paragraph 41JA (2) (a) of the Act, the notice period for a kind
of medical device in relation to which a person is required, by written notice
given by the Secretary under subsection 41JA (1) of the Act, to give
information to the Secretary is:
- (a)
- if the information relates to
manufacturing records — 5 years; and
- (b)
- if the information relates to distribution records:
- (i)
- in the case of records relating to a Class AIMD medical device, Class III
medical device, or Class IIb medical device that is an implantable
medical device — 10 years; and
- (ii)
- in the case of records relating to any other device —
5 years.
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