Malaysia legislation

Section 2

of *MEDICAL DEVICE ACT 2012

Section 2

In this Act, unless the context otherwise requires—

“conformity assessment body” means the conformity assessment body registered under section 12;

“prescribed”, unless otherwise specified, means prescribed by regulations made under this Act;

10 Laws of Malaysia ACT 737

“establishment” means—

(a)

a person who is either a manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include a retailer; and

(b)

an authorized representative appointed by a manufacturer having a principal place of business outside Malaysia, and such person and authorized representative being—

(A)

a person domiciled or resident in Malaysia; or

(B)

a firm or company constituted under the laws of Malaysia, and carrying on business or practice principally in Malaysia;

“place in the market” means to make available a medical device in return for payment or free of charge with a view to distributing, using, supplying or putting it into service, in Malaysia, regardless of whether it is new or reprocessed, but does not include to make available for use for clinical research or for performance evaluation of a medical device;

“Minister” means the Minister charged with the responsibility for health;

“manufacturer” means—

(a)

a person who is responsible for—

(i)

the design, production, fabrication, assembly, processing, packaging and labelling of a medical device whether or not it is the person, or a subcontractor acting on the person’s behalf, who carries out these operations; and

(ii)

assigning to the finished medical device under his own name, its intended purpose and ensuring the finished product meets the regulatory requirement; or

(b)

any other person who—

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(i)

assembles, packages, processes, fully refurbishes, reprocesses or labels one or more ready-made medical devices; and

(ii)

assigning to the ready-made medical device under his own name, its intended purpose and ensuring the finished product meets the regulatory requirement, but shall not include the following persons:

(A)

any person who assembles or adapts medical devices in the market that are intended for individual patients; and

(B)

any person who assembles, packages or adapts medical devices in relation to which the assembling, packaging or adaptation does not change the purpose intended for the medical devices;

“medical device” means—

(a)

any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of—

(i)

diagnosis, prevention, monitoring, treatment or alleviation of disease;

(ii)

diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

(iii)

investigation, replacement or modification, or support of the anatomy or of a physiological process;

(iv)

support or sustaining life;

(v)

control of conception;

(vi)

disinfection of medical device; or

12 Laws of Malaysia ACT 737

(vii)

providing information for medical or diagnostic purpose by means of in-vitro examination of specimens derived from the human body, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; and

(b)

any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a medical device by order published in the Gazette;

“designated medical device” means a medical device specified by the

Minister to be a designated medical device by order published in the Gazette;

“Authority” means the Medical Device Authority established under the

Medical Device Authority Act 2012 [Act 738];

“appointed date” means the date appointed by the Minister under subsection 1(2).

Read in full context — *MEDICAL DEVICE ACT 2012 →