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Section 24

Renewal of establishment licence

of Medical Device Act 2012

ActIn forceProvision 24 of 80
Section 24
(1)

A licensee may apply for renewal of its establishment licence to the

Authority not later than one year before the expiry date of the establishment licence.

(2)

The Authority shall, upon payment of the prescribed fee, renew an establishment licence except in the following circumstances:

(a)

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

(b)

the licensee has breached any condition of the establishment licence;

(c)

the licensee had improperly or illegally obtained the establishment licence; or

(d)

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

(3)

The Authority may request the licensee to provide any information, particulars or document as may be required for the renewal application within the period specified in the request.

(4)

Notwithstanding subsection (2), if the information, particulars or document requested under subsection (3) is not provided by the licensee within

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the period specified in the request or any extension of time granted, the

Authority may not renew the establishment licence.