Obligation to include kinds of medical devices in the Register
41FF Obligation to include kinds of medical devices in the Register
If:
an application for a kind of medical device to be included in the Register in relation to a person has passed preliminary assessment; and
the application has not been selected for audit under section 41FH;
the Secretary must include the kind of device in the Register in relation to the person.
However, the Secretary must not include the kind of device in the Register in relation to the person if the Secretary is satisfied that the kind of device is to be used exclusively for one or more of the purposes specified under section 41BEA.
As soon as practicable after the kind of device has been included in the Register, the Secretary must make available to the applicant a certificate of the inclusion of the kind of device in the Register.
The certificate must specify the day on which the inclusion of the kind of device in the Register commences.
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