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Section 22

Suspension or revocation of establishment licence

of Medical Device Act 2012

ActIn forceProvision 22 of 80
Section 22
(1)

The Authority may suspend or revoke an establishment licence if the licensee—

(a)

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

(b)

has breached any condition of the licence; or

(c)

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

(2)

If an establishment licence is suspended under subsection (1), the

Authority may require the licensee to remedy the contravention or the breach within the period specified by the Authority.

(3)

If the Authority is satisfied that the licensee has failed to remedy the contravention or breach as required under subsection (2), or the contravention or breach continues after the establishment licence is suspended under subsection (1), the Authority shall revoke the licence.

22 Laws of Malaysia ACT 737