Malaysia legislation
Section 35
Section 35
(2)
The Authority shall, upon payment of the prescribed fee, renew a designated medical device permit except in the following circumstances:
(a)
the permit holder has contravened any provision of this Act or any regulations made under this Act;
(b)
the permit holder has breached any condition of the designated medical device permit;
(c)
the permit holder had improperly or illegally obtained the designated medical device permit; or
(d)
the permit holder has been convicted of an offence under this Act or any regulations made under this Act.
(3)
The Authority may request the permit holder 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 permit holder within the period specified in the request or any extension of time granted, the
Authority may not renew the designated medical device permit.
Effect of suspension, revocation, surrender or non-renewal of designated medical device permit