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Section 33

Suspension or revocation of designated medical device permit

of Medical Device Act 2012

ActIn forceProvision 33 of 80
Section 33
(1)

The Authority may suspend or revoke a designated medical device permit if the permit holder—

(a)

has contravened any provision of this Act or any regulations made under this Act;

(b)

has breached any condition of the designated medical device permit; or

(c)

has been convicted of an offence under this Act or any regulations made under this Act.

(2)

If a designated medical device permit is suspended under subsection

(1)

, the Authority may require the permit holder to remedy the contravention or breach within the period specified by the Authority.

(3)

If the Authority is satisfied that the permit holder has failed to remedy the contravention or breach as required under subsection (2), or the contravention or breach continues after the designated medical device permit is suspended under subsection (1), the Authority shall revoke the designated medical device permit.