Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4.2

Considering applications for conformity assessment certificates (Act s 41EC)

    For subsection   41EC(2) of the Act, the following other requirements of the conformity assessment procedures are specified:

  (a)   the applicable requirements in relation to the establishment and maintenance of a post - market monitoring, reporting and corrective action system;

  (b)   the applicable requirements in relation to the keeping of records.


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