Section 14
Power to cancel registration of conformity assessment body
Subject to subsection (2), the Authority may cancel the registration of conformity assessment body that—
(a)
has contravened any provision of this Act or any regulations made under this Act;
(b)
has breached any condition of the registration; or
(c)
has been convicted of an offence under this Act or any regulations made under this Act.
(2)
Before the cancellation of the registration of a conformity assessment body under subsection (1), the Authority shall, by notice in writing, give the conformity assessment body an opportunity to show cause against the cancellation, and pending the decision of the cancellation, all assessment of any medical device by that conformity assessment body shall be suspended from the date of the receipt of the notice by the conformity assessment body.
(3)
A conformity assessment body whose registration is cancelled shall not be entitled to any compensation for any loss caused to it by the cancellation and shall not be entitled to any refund of the prescribed registration fee paid under section 12.
Medical Device 19