MEDICAL DEVICE ACT 2012

LAWS OF MALAYSIA ONLINE VERSION OF UPDATED TEXT OF REPRINT Act 737 MEDICAL DEVICE ACT 2012 As at 1 March 2017 2 MEDICAL DEVICE ACT 2012 Date of Royal Assent … … … … … 30 January 2012 … … … 9 February 2012 Date of publication in the Gazette 3 LAWS OF MALAYSIA Act 737 MEDICAL DEVICE ACT 2012 ARRANGEMENT OF SECTIONS PART I PRELIMINARY Section 1. Short title and commencement 2. Interpretation PART II REGISTRATION OF MEDICAL DEVICE AND CONFORMITY ASSESSMENT BODY Chapter 1 Registration of medical device 3. Classification of medical device 4. Manufacturer’s obligations 5. Requirement for registration of medical device 6. Application for registration of medical device 7. Registration and refusal to register medical device 8. Power to impose additional conditions and to vary or revoke conditions 9. Power to cancel registration of medical device 4 Laws of Malaysia ACT 737 Chapter 2 Registration of conformity assessment body Section 10. Conformity assessment body 11. Requirement for registration of conformity assessment body 12. Registration and refusal to register conformity assessment body 13. Power to impose additional conditions and to vary or revoke conditions 14. Power to cancel registration of conformity assessment body PART III LICENCE AND PERMIT Chapter 1 Establishment licence 15. Requirement for establishment licence 16. Application for establishment licence 17. Additional information or document 18. Grant or refusal of establishment licence 19. Compliance with establishment licence conditions 20. Power to impose additional conditions and to vary or revoke conditions 21. Transfer of establishment licence 22. Suspension or revocation of establishment licence 23. Surrender of establishment licence 24. Renewal of establishment licence 25. Effect of suspension, revocation, surrender or non-renewal of establishment licence Chapter 2 Designated medical device permit 26. Designated medical device 27. Requirement for designated medical device permit Medical Device Section 28. Application for designated medical device permit 29. Additional information or document 30. Grant or refusal of designated medical device permit 31. Compliance with designated medical device permit conditions 32. Power to impose additional conditions and to vary or revoke conditions 33. Suspension or revocation of designated medical device permit 34. Surrender of designated medical device permit 35. Renewal of designated medical device permit 36. Effect of suspension, revocation, surrender or non-renewal of designated medical device permit Chapter 3 Duties and obligations of licensees or permit holders 37. Distribution records 38. Post-market surveillance and vigilance 39. Complaint handling 40. Mandatory problem reporting 41. Field corrective action 42. Recall Chapter 4 General duty 43. Usage, operation, maintenance, etc., of medical device 44. Advertising Chapter 5 Export permit 45. Export permit 46. Revocation of export permit 5 6 Laws of Malaysia PART IV APPEAL Section 47. Appeal against decision of Authority PART V ENFORCEMENT 48. Authorized officers 49. Authority card 50. Power of investigation 51. Search and seizure with warrant 52. Search and seizure without warrant 53. Access to computerized data 54. Warrant admissible notwithstanding defects 55. List of medical device, book, document, etc., seized 56. Release of medical device, book, document, etc., seized 57. No costs or damages arising from seizure to be recoverable 58. Cost of holding seized medical device, etc. 59. Obstruction to search 60. Power to require attendance of persons acquainted with case 61. Examination of persons acquainted with case 62. Admission of statements in evidence 63. Forfeiture of seized medical device, etc. 64. Power of arrest 65. Power to take sample 66. Appointment of analyst PART VI GENERAL 67. Register 68. Confidential business information ACT 737 Medical Device Section 69. Public disclosure 70. Emergency response plan and assistance from multi-agencies in emergency 71. Compounding of offences 72. Prosecution 73. Offence by body corporate 74. Offence by partner, agent or servant 75. Service of document 76. False declaration 77. Power to exempt 78. General penalty 79. Regulations 80. Savings and transitional 7 9 LAWS OF MALAYSIA Act 737 MEDICAL DEVICE ACT 2012 An Act to regulate medical devices, the industry and to provide for matters connected thereto. [30 June 2013, P.U. (B) 126/2013] 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 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— “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— Medical Device 11 (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, compensation for an injury; alleviation of or (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). PART II REGISTRATION OF MEDICAL DEVICE AND CONFORMITY ASSESSMENT BODY Chapter 1 Registration of medical device Classification of medical device 3. (1) A medical device shall be classified by an establishment based on the level of risk it poses, its intended use and the vulnerability of the human body in accordance with the prescribed manner. Medical Device 13 (2) In the event of any dispute between an establishment and a conformity assessment body over a classification of a medical device, the matter shall be referred to the Authority, in the manner and within such period as may be specified by the Authority, for its decision. Manufacturer’s obligations 4. A manufacturer shall ensure that a medical device— (a) conforms to the prescribed essential principles of safety and performance; (b) is manufactured in accordance with good manufacturing practice and any written directive issued by the Authority; and (c) is labelled, packaged and marked in accordance with the prescribed manner. Requirement for registration of medical device 5. (1) No medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act. (2) Any person who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding three years or to both. Application for registration of medical device 6. (1) An application for the registration of a medical device shall be made by an establishment to the Authority in the prescribed manner. (2) An application may be withdrawn at any time by the applicant before it is approved or refused by the Authority. 14 Laws of Malaysia ACT 737 (3) Every application under subsection (1) shall be accompanied by the prescribed application fee and such document or information as may be specified by the Authority. (4) The Authority may, in writing, at any time after the receipt of an application under subsection (1), request the applicant to give to the Authority within the period specified in the request additional information, particulars or document on the application or sample of the medical device. (5) If any additional information, particulars or document, or sample of the medical device required under subsection (4) is not given by the applicant within the period specified in the request or any extension of time granted by the Authority, the application shall be deemed to be withdrawn and shall not be further proceeded with, but without affecting the right of the applicant to make a fresh application. Registration and refusal to register medical device 7. (1) Upon receipt of an application made under section 6 and the Authority being satisfied that— (a) the medical device has been subjected to the conformity assessment procedures carried out by a conformity assessment body; and (b) the applicant has complied with any requirement of the Authority made under subsectio