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Withdrawal or Cancellation

Withdrawal 

According to Section 6(2) of Act 737;  

An application may be withdrawn at any time by the applicant before it is approved or refused by the Authority. 

 

Cancellation

According to Section 9 of Act 737; "Power to cancel registration of medical device"

(1) subject to subsection (2), the Authority may cancel the registration of a medical device if the establishment on whose application a medical device is registered—

(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 medical device under subsection (1), the Authority shall, by notice in writing, give the establishment on whose application the medical device is registered an opportunity to show cause against the cancellation, and pending the decision on the cancellation, all importation or supply of the medical device by that establishment shall be suspended from the date of the receipt of the notice by the establishment.

(3) An establishment whose registration of medical device 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 7.

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my