Section 40
Mandatory problem reporting
An establishment shall report to the Authority any incident that comes to the establishment’s attention occurring inside or outside Malaysia that—
(a)
is related to the failure of the medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its instructions for use and such report shall be made within thirty days from the discovery;
(b)
has led to the death or serious deterioration in the state of health of a patient, user or other person, or could do so were the incident to recur and such report shall be made within ten days from the discovery; or
(c)
is a serious threat to public health and such report shall be made within forty-eight hours from the discovery.
(2)
Any person who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding two years or to both.
30 Laws of Malaysia ACT 737