Malaysia legislation
Section 75
Section 75
(2)
Where in the opinion of the Director General the use of any apparatus, appliance, equipment, instrument, substance or any activity in a private healthcare facility or service or the manner in which any blood, blood product, human tissue or fluid or any product of the human body, substance or sample 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 used, the Director General may, by notice, direct the holder of the approval, licensee or the holder of a certificate of registration in respect of such facility or service to stop using the apparatus, appliance, equipment, instrument or substance or to stop the activity.
(3)
The Director General may, by notice, further direct the holder of the approval, licensee or the holder of a certificate of registration to install or replace such apparatus, appliance, equipment, instrument, substance or any activity therein, and to adhere to such procedures as may be specified in the notice.
(4)
The holder of the approval, licensee or the holder of a certificate of registration who fails to comply with the directions of the Director General under this section commits an offence and shall be liable on conviction—
(a)
in the case of a sole proprietor—
(i)
to a fine not exceeding twenty thousand ringgit or to imprisonment for a term not exceeding four months or to both; and
60 Laws of Malaysia ACT 586
(ii)
in the case of a continuing offence, to a fine of one thousand ringgit for every day or part of the day during which the offence continues after conviction;
(b)
in the case of a body corporate, partnership or society—
(i)
to a fine not exceeding fifty thousand ringgit; and
(ii)
in the case of a continuing offence, to a fine of five thousand ringgit for every day or part of the day during which the offence continues after conviction.
(5)
Where an offence under this section is committed by a body corporate, partnership or society—
(a)
in the case of a body corporate, the person responsible for the body corporate;
(b)
in the case of a partnership, every partner in the partnership;
(c)
in the case of a society, its office bearers, shall also be guilty of the offence and shall be liable on conviction—
(aa) to a fine not exceeding twenty thousand ringgit or to imprisonment for a term not exceeding four months or to both; and
(bb) in the case of a continuing offence, to a fine of one thousand ringgit for every day or part of the day during which the offence continues after conviction.
Power of Director General to issue directives, orders or guidelines relating to quality assurance