Malaysia legislation
Section 45
Section 45
(2)
Where the Director General is of the opinion that any prescribed requirement or standard which applies to a licensed pathology laboratory is not being observed by a licensee, the
Director General may give to the licensee such directives in writing as he thinks necessary for the observance of the requirement or standard and shall state in the directives the period within which the licensee is required to comply with the directives.
(3)
Where the Director General is of the opinion that the use of any equipment in a licensed pathology laboratory or the manner in which any product of the human body is used, collected, handled, stored or transported, or any other activity conducted is detrimental to the health and safety of any person therein or is otherwise unsuitable for the purpose for which it is intended,
Pathology Laboratory 41
the Director General may, by a written notice, direct the licensee to stop using the equipment or product of the human body or to stop the activity.
(4)
The Director General may, by a written notice, further direct the licensee to install or replace such equipment or replace the activity therein, and to adhere to such procedures as may be specified in the notice.
(5)
The licensee who fails to comply with the directives of the Director General under this section commits an offence.