MEDICAL DEVICE AUTHORITY ACT 2012

LAWS OF MALAYSIA ONLINE VERSION OF UPDATED TEXT O REPRINT Act 738 MEDICAL DEVICE AUTHORITY ACT 2012 As at 1 July 2020 2 MEDICAL DEVICE AUTHORITY ACT 2012 … … 30 January 2012 Date of publication in the Gazette … 9 February 2012 Date of Royal Assent 3 LAWS OF MALAYSIA Act 738 MEDICAL DEVICE AUTHORITY ACT 2012 ARRANGEMENT OF SECTIONS PART I PRELIMINARY Section 1. Short title and commencement 2. Interpretation PART II THE AUTHORITY 3. Establishment of the Authority 4. Membership of the Authority 5. Tenure of office 6. Allowances 7. Chairman 8. Revocation of appointment and resignation 9. Vacation of office 10. Committees 11. Disclosure of interest 4 Laws of Malaysia PART III FUNCTIONS AND POWERS OF THE AUTHORITY Section 12. Functions and powers of the Authority 13. Delegation of the Authority’s functions and powers 14. Power of Minister to give directions 15. Returns, reports, accounts and information PART IV OFFICERS AND SERVANTS OF THE AUTHORITY 16. Chief Executive 17. Appointment of other officers and servants 18. Loans and advances 19. Payment of retirement benefits, etc. 20. Authority may adopt regulations, etc. 21. Employment 22. Continuation and completion of disciplinary proceedings PART V FINANCE 23. The Fund 24. Expenditure to be charged on the Fund 25. Conservation of Fund 26. Expenditure and preparation of estimates 27. Bank accounts 28. Power to borrow 29. Investment 30. Financial procedure 31. Financial year 32. Accounts and reports ACT 738 Medical Device Authority Section 33. Payment to the Federal Consolidated Fund PART VI GENERAL 34. Institution of prosecution 35. Public Servant 36. Public Authorities Protection Act 1948 37. Obligation of secrecy 38. Representation in civil proceedings 39. Power to employ 40. Regulations 41. Acts done in anticipation of the enactment of this Act SCHEDULE 5 7 LAWS OF MALAYSIA Act 738 MEDICAL DEVICE AUTHORITY ACT 2012 An Act to provide for the establishment of the Medical Device Authority, to control and regulate medical device, the medical device industry and its activities, and to enforce the medical device laws, and for related matters. [15 March 2012, P. U. (B) 73/2012] ENACTED by the Parliament of Malaysia as follows: PART I PRELIMINARY Short title and commencement 1. (1) This Act may be cited as the Medical Device Authority Act 2012. (2) This Act comes into operation on a date to be appointed by the Minister by notification in the Gazette. Interpretation 2. In this Act, unless the context otherwise requires— “member” means a member of the Authority under section 4; 8 Laws of Malaysia ACT 738 “committee” means a committee established under section 10; “Fund” means the Fund established under section 23; “Minister” means the Minister charged with the responsibility for health; “Chairman” means the Director General of Health; “Authority” means the Medical Device Authority established under section 3; “appointed date” means the date appointed under subsection 1(2); “medical device laws” means this Act and the Medical Device Act 2012 [Act 737], and includes any subsidiary legislation made under these laws. PART II THE AUTHORITY Establishment of the Authority 3. (1) A body corporate with the name “Medical Device Authority” is established. (2) The Authority shall have perpetual succession and a common seal. (3) The Authority may sue and be sued in its name. (4) Subject to and for the purposes of this Act, and upon such terms as it deems fit, the Authority may— (a) enter into contracts; (b) acquire, purchase, take, lease, hold, sell and enjoy movable and immovable property of every description; and Medical Device Authority 9 (c) convey, assign, surrender, yield up, charge, mortgage, demise, reassign, transfer, or otherwise dispose of, or deal with any movable or immovable property or any interest in any movable or immovable property, vested in the Authority. Membership of the Authority 4. (1) The Authority shall consist of the following members: (a) the Director General of Health as a Chairman; (b) the Chief Executive; (c) a representative of the Ministry of Finance; (d) a representative of the Ministry of Health; and (e) not more than five persons with expertise and experience in medical device matters to be appointed by the Minister. (2) The provisions of the Schedule shall apply to the Authority. (3) The Minister may amend the Schedule by order published in the Gazette. Tenure of office 5. (1) Subject to such conditions as may be specified in his instrument of appointment, every member of the Authority appointed under paragraph 4(1)(e) shall, unless he sooner resigns or vacates his office or his appointment is sooner revoked, hold office for a term not exceeding three years. (2) Every member of the Authority appointed under paragraph 4(1)(e) shall be eligible for reappointment but no member shall hold office for more than two consecutive terms. 10 Laws of Malaysia ACT 738 Allowances 6. (1) The Chairman shall be paid such allowances as the Minister may determine after consultation with the Minister of Finance. (2) All other members of the Authority, other than the Chief Executive, shall be paid such allowances as the Minister may determine after consultation with the Minister of Finance. Chairman 7. (1) The Chairman of the Authority shall preside at all meetings of the Authority. (2) In the absence of the Chairman for any reason, he shall appoint the Deputy of Director General of Health to carry out the duties of the Chairman. Revocation of appointment and resignation 8. (1) The appointment of a member of the Authority, other than the members appointed under paragraphs 4(1)(a), (b), (c) and (d), may at any time be revoked by the Minister. (2) A member, other than the Chief Executive, may at any time resign his office by a written notice addressed to the Minister. Vacation of office 9. The office of a member of the Authority, other than Chief Executive, shall be vacated if— (a) he dies; (b) there has been proved against him, or he has been convicted of, a charge in respect of— Medical Device Authority 11 (i) an offence involving fraud, dishonesty or moral turpitude; (ii) an offence under any law relating to corruption; or (iii) any other offence punishable with imprisonment (in itself only or in addition to or in lieu of a fine) for more than two years; (c) his conduct, whether in connection with his duties as a member of the Authority or otherwise, has been such as to bring discredit to the Authority; (d) he becomes a bankrupt; (e) he is of unsound mind or is otherwise incapable of discharging his duties; (f) in the case of the Chairman, he absents himself from three consecutive meetings of the Authority without leave from the Minister; (g) in the case of a member of the Authority, other than the Chairman, he absents himself from three consecutive meetings of the Authority without leave of the Chairman; (h) his resignation is accepted by the Minister; or (i) his appointment is revoked by the Minister. (2) Where a member appointed under paragraph 4(1)(e) ceases to be a member of the Authority, the Minister may appoint another person to fill the vacancy for the remainder of the term for which the vacating member was appointed in accordance with the provisions applying. 12 Laws of Malaysia ACT 738 Committees 10. (1) The Authority may establish any committee it considers necessary or expedient to assist it in the performance of its functions under this Act. (2) The Authority may elect any of its members to be the chairman of a committee established under subsection (1). (3) The Authority may appoint any person to be a member of a committee. (4) A member of a committee shall hold office for such term as may be specified in his letter of appointment and is eligible for reappointment. (5) The Authority may, at any time, revoke the appointment of a member of a committee. (6) A member of a committee may, at any time, resign his office by a written notice addressed to the chairman of the committee. (7) The Authority may, at any time, discontinue the constitution or alter the composition of a committee. (8) A committee may regulate its own procedure. (9) A committee shall be subject to, and act in accordance with, any direction given to it by the Authority. (10) Meetings of a committee shall be held at such times and places as the chairman of the committee may determine. (11) A committee shall cause— (a) minutes of all its meetings to be maintained and kept in proper form; and (b) copies of the minutes of all its meetings to be submitted to the Authority as soon as practicable. Medical Device Authority 13 (12) A committee may invite any person to attend any of its meetings for the purpose of advising it on any matter under discussion but that person shall not be entitled to vote at the meeting. (13) The members of a committee and any person invited under subsection (12) shall be paid such allowances and other expenses as the Authority may determine. Disclosure of interest 11. (1) A member of the Authority or any committee established under section 10 who has or acquires a direct or indirect interest by himself, through a member of his family or his associate in relation to any matter under discussion by the Authority or committee, as the case may be, shall disclose to the Authority or committee, as the case may be, the fact of his interest and the nature of that interest. (2) A disclosure under subsection (1) shall be recorded in the minutes of the meeting of the Authority or the committee, as the case may be, in which the matter is discussed and, after the disclosure the member— (a) shall not be present or take part in any discussion or decision of the Authority or committee, as the case may be, about the matter; and (b) shall be disregarded for the purpose of constituting a quorum of the meeting of the Authority or committee, as the case may be, when the matter is discussed or decided upon. (3) A member of the Authority or committee who fails to disclose his interest as required under subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding six months or to both. 14 Laws of Malaysia ACT 738 (4) No act or proceedings of the Authority or committee shall be invalidated on the ground that any member of the Authority or committee has contravened this section. (5) For the purposes of subsection (1)— “a member of his family” includes— (a) his spouse; (b) his parent (including a parent of his spouse); (c) his child (including an adopted child or stepchild); (d) his brother or sister (including a brother or sister of his spouse); and (e) a spouse of his child, brother or sister; and “associate” means— (a) a person who is a nominee or an employee of the member; (b) a firm of which the member or any nominee of his is a partner; (c) a partner of the member; (d) a trustee of a trust under which the member or a member of his family is a beneficiary; or (e) any corporation within the meaning of the Companies Act 1965 [Act 125], of which the member or any nominee of his or a member of the  NOTE—The Companies Act 1965 [Act 125] has since been repealed by the Companies Act 2016 [Act 777] which comes into operation on 31 January 2017―see subsection 620(1) of Act 777. Medical Device Authority 15 member’s family is a director or has a substantial shareholding in the corporation. PART III FUNCTIONS AND POWERS OF THE AUTHORITY Functions and powers of the Authority 12. (1) The Authority shall have all the functions and powers imposed on it under the medical device laws and shall also have the following functions: (a) to implement and enforce and to consider and recommend reform to the medical device laws; (b) to regulate all matters relating to medical device and the medical device industry