Section 79
Regulations
The Minister may make such regulations as may be expedient or necessary for the better carrying out of the provisions of this Act.
(2)
Without prejudice to the generality of subsection (1), regulations may be made for the following purposes:
(a)
to prescribe the manner of application for the registration of a medical device or conformity assessment body, licences or permits, and to provide for the cancellation of the registration, and suspension and revocation of the licence or permit;
(b)
to prescribe the risk classification criteria, the manner of classification and the rules of classification of medical devices;
(c)
to prescribe the design and manufacturing principles of medical devices, the good design principles in relation to risk elimination or minimization, and the good manufacturing principles in relation to standards, safety and efficacy of medical devices;
(d)
to prescribe all matters relating to the packaging, labelling and marking of medical devices for the purpose of identification;
(e)
to prescribe procedures and criteria for conformity assessment of medical devices;
(f)
to prescribe the conformity assessment standards for various class or categories of medical devices;
(g)
to prescribe the manner of keeping and maintaining the register;
52 Laws of Malaysia ACT 737
(h)
to prescribe matters relating to the contents of and conditions for advertising of medical devices;
(i)
to prescribe the manner of maintenance and the contents of distribution records of medical devices;
(j)
to prescribe the criteria, conditions and the procedures for post-market surveillance and vigilance, complaint handling, mandatory problem reporting, field corrective action and the usage, operation, installation, test, commission, maintenance and disposal of medical devices;
(k)
to prescribe the procedure for voluntary recall by an establishment, the criteria, conditions and procedures for mandatory recall by the
Authority, taking out of operation of medical devices and disposal of medical devices which are no longer safe to use;
(l)
to prescribe matters relating to export permits including the criteria, conditions and the procedure for the application of export permits of medical devices;
(m)
to prescribe the competency requirement of persons using, operating, installing, testing, commissioning, maintaining and disposing of medical devices; and
(n)
to prescribe the fees and charges payable under this Act and the manner for collecting and dealing with such fees and charges.
(3)
The regulations made under this Act may provide for any act or omission in contravention of the regulations to be an offence and may provide for penalties of a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding two years or to both.