Section 43
Section 43
A person using or operating a medical device on a third party shall ensure that the medical device is—
Medical Device 31
(a)
safe and efficacious;
(b)
used in accordance with its intended purpose;
(c)
used in accordance with the manufacturer’s instructions; and
(d)
properly installed, tested, commissioned and maintained.
(2)
A person—
(a)
using or operating a medical device on a third party; or
(b)
installing, testing, commissioning, maintaining and disposing of a medical device, shall have the qualification and competency as prescribed by the Minister.
(3)
A person using or operating a medical device on a third party shall take the medical device out of operation when it is no longer safe and effective for use.
(4)
A medical device which has been taken out of operation under subsection (3) shall be removed and disposed of in a safe manner which eliminates or reduces any—
(a)
danger of injury;
(b)
danger of contamination with biological material or other contaminants;
(c)
danger of environmental damage; and
(d)
danger of it being re-used.
(5)
The Authority may issue directives, orders or guidelines to specify the measures to be taken in the event of an emergency or incident during the usage, operation, installation, testing, commissioning, maintenance and disposal of medical devices.
32 Laws of Malaysia ACT 737
(6)
Any person who contravenes subsection (1), (2), (3) or (4) commits an offence and shall, on conviction, be liable to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding one year or to both.