World Health Organization Guidance

Governments

need to put in place policies that will address all elements related to medical devices, ranging from access to high quality, affordable products, through their safe and appropriate use and disposal.

Policies will be unsuccessful unless they are translated into national regulations that are enforced by legislation and correlating sanctions, and that form an integral part of the overall national health system.

Source: Medical device regulations: Global overview and guiding principles; World Health Organization, Geneva; 2003

(At: http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf )

INTRODUCTION TO MEDICAL DEVICE ACT 2012 (ACT 737)

IDAMAZURA IDRIS @ HARUN
MEDICAL DEVICE CONTROL DIVISION, MINISTRY OF HEALTH LEVEL 5, MENARA PRISMA, PERSIARAN PERDANA PRECINCT 3, PUTRAJAYA

CONTENT
Background Arrangement of Sections Medical Device Act 2012 (Act 737)
Part I Preliminary Part II: Registration Of Medical Device And Conformity Assessment Body Part III: Licence and Permit Part IV: Appeal Part V: Enforcement Part VI: General

Summary

BACKGROUND
16 Feb 2005: Cabinet approved the proposal to develop Medical Device Regulatory Program in Malaysia
Development of MD Bill & subsidiary legislations

August 2005: Establishment of Medical Devices Control Division

Establishment of an organization to implement MD Regulatory Program

Development of MD Registration & Surveillance/ Vigilance System
MEDICAL DEVICES CONTROL DIVISION, Ministry of Health Malaysia

MEDICAL DEVICE REGULATORY FRAMEWORK

Objectives- Medical Device Regulation

Unavailability of pre-market control to assess safety, effectiveness and quality of medical devices Inadequate information for the public and health professionals to make informed choices on medical devices Lack of control over the usage of certain medical devices No post-market reporting system to identify and monitor medical devices with problems in the market To facilitate our local manufacturers to market their products globally To provide a favourable environment for the growth of medical device industry

Harmonised medical device regulation

Definition-GHTF/WHO Risk Based Classification GHTF Risk Based Regulation Regulatory Model WHO Model

MEDICAL DEVICES REGULATORY FRAMEWORK IN MALAYSIA:

W.H.O. REGULATORY MODEL-life cycle

Stages of Regulatory Control

The safety and performance of medical device must be assured through out its life span.

DISTRIBUTOR/
IMPORTER

Participants in ensuring the safety of medical device

MEDICAL DEVICES ACT 2012 ACT 737

 The initial drafting activities was started in 2006

(which includes research of other regulatory frameworks, benchmark of the best practices, series of discussion with stakeholders and the actual drafting process).

The Act was

approved by Dewan Negara on 7th December 2011, received Royal Assent on 30th January 2012, and published in the Gazette on 9th February 2012.

ARRANGEMENT OF SECTIONS
This Act is divided into six parts:
Part I Preliminary Part II Registration of Medical Device and Conformity Assessment Body Part III Licence and Permit Part IV Appeal Part V Enforcement Part VI General

And consist of 80 sections.

MEDICAL DEVICE ACT (ACT 737)

Long title:
An Act to regulate medical devices, the industry and to provide for matters connected thereto.

It is enacted by the Parliament.

MEDICAL DEVICE ACT (ACT 737) Part I: Preliminary

PART I: PRELIMINARY
This part provides the short title and commencement of the Act and interpretation. Section 1(1) This Act may be cited as the Medical Device Act 2012. Section 1(2) This Act comes into operation on a date to be appointed by the Minister by notification in the Gazette. Section 2 provides interpretation of terminologies used in this Act. Interpretations specify the scopes of the Act.

SECTION 2 - INTERPRETATION
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

SECTION 2 - INTERPRETATION
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 persons 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

SECTION 2 - INTERPRETATION
(b) any other person who: (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

SECTION 2 - INTERPRETATION
medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of:
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) compensation for an injury; (iii) investigation, replacement, modification, or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) control of conception; (vi) disinfection of medical devices; (vii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

SECTION 2 - INTERPRETATION
which DOES NOT achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which 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.

MEDICAL DEVICE ACT (ACT 737) Part II: Registration Of Medical Device And Conformity Assessment Body

PART II: REGISTRATION OF MEDICAL DEVICE AND CONFORMITY ASSESSMENT BODY

Provides requirements for registration. Consist of 2 chapters;
i. Chapter 1: Registration of medical device (from section 3 up to section 9) ii. Chapter 2: Registration of Conformity Assessment Body (from section 10 to section 14)

CHAPTER 1: REGISTRATION OF MEDICAL DEVICE

Detailed out requirements in 7 sections;
Section 3: Classification of medical device Section 4: Manufacturers obligation Section 5: Requirement for registration of medical device Section 6: Application for registration of medical device Section 7: Registration and refusal to register medical device Section 8: Power to impose additional conditions and to vary or revoke conditions Section 9: Power to cancel registration of medical device

CHAPTER 1: REGISTRATION OF MEDICAL DEVICE

Section 3 (1) provide that classification of medical device should be done by an establishment based on the level of risk it poses, its intended use and vulnerability of the human body in accordance with the prescribed manner. In the case of dispute between an establishment and a conformity assessment body, the classification can be referred to the Authority for its decision in manner specified in section 3(2).

CHAPTER 1: REGISTRATION OF MEDICAL DEVICE

Section 4 specify manufacturers obligation to ensure a medical device - conforms to the prescribed essential principles of safety and performance; - is manufactured in accordance with good manufacturing practice (based on ISO 13485) and any written directive issued by the Authority; and - is labelled, packaged and marked in accordance with the prescribed manner.

CHAPTER 1: REGISTRATION OF MEDICAL DEVICE

Section 5 specify the requirement for medical device registration before the device can be marketed.
Section 5(1) No medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act.
Section 5(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.

CHAPTER 2: REGISTRATION OF CONFORMITY ASSESSMENT BODY

Detailed out requirements in 7 sections;
Section 10: Conformity assessment body Section 11: Requirement for registration of conformity assessment body Section 12: Registration and refusal to register conformity assessment body Section 13: Power to impose additional conditions and to vary or revoke conditions Section 14: Power to cancel registration of conformity assessment body

CHAPTER 2: REGISTRATION OF CONFORMITY ASSESSMENT BODY

Section 10 specify
the definition of conformity assessment body (Sub-section (1)), the citizenship of the person who is in charge of and has overall control over a conformity assessment body (Subsection (2)), the independence matter (to address conflict of interest concern) (Sub-section (3)), disclosure of information requirements (Sub-section (4)), and audit requirements for conformity assessment body (Subsection (5)).

CHAPTER 2: REGISTRATION OF CONFORMITY ASSESSMENT BODY

Section 11 (1) specify the requirement for conformity assessment registration under the Act.
Section 11(1) No conformity assessment body may carry out any conformity assessment related to a medical device unless it is registered under this Act.

MEDICAL DEVICE ACT (ACT 737) Part III: Licence and Permit

PART III: LICENCE AND PERMIT

Chapter I: Establishment licence Chapter 2: Designated Medical Device Permit Chapter 3:Duties and obligation of licensees or permit holders Chapter 4: General Duty Chapter 5: Export permit

CHAPTER 1: ESTABLISHMENT LICENCE

Detailed out requirements in 11 sections : Section 15: Requirement for establishment licence Section 16: Application for establishment licence Section 17: Additional information or document Section 18: Grant or refusal of establishment licence Section 19: Compliance with establishment licence conditions Section 20: Power to impose additional conditions and to vary or revoke conditions Section 21: Transfer of establishment licence Section 22: Suspension or revocation of establishment licence Section 23: Surrender of establishment licence Section 24: Renewal of establishment licence Section 25: Effect of suspension, revocation, surrender or non-renewal of establishment licence

CHAPTER 1: ESTABLISHMENT LICENCE

Section 15(1) and (2) gives provision on the requirement for establishment licencing under the Act and the fine if the offence under subsection (1) is committed.
Section 15(1) No establishment shall import, export or place in the market any registered medical device unless it holds an establishment licence granted under this Act.
Section 15(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.

CHAPTER 2: DESIGNATED MEDICAL DEVICE PERMIT

Detailed out requirements in 11 sections :Section 26: Designated medical device Section 27: Requirement for designated medical device permit Section 28: Application for designated medical device permit Section 29: Additional information or document Section 30: Grant or refusal of designated medical device permit Section 31: Compliance with designated medical device permit conditions

CHAPTER 2: DESIGNATED MEDICAL DEVICE PERMIT

Section 31: Power to impose additional conditions and to vary or revoke conditions Section 32: Suspension or revocation of designated medical device permit Section 33: Surrender of designated medical device permit Section 34: Renewal of designated medical device permit Section 35: Effect of suspension, revocation, surrender or nonrenewal of designated medical device permit

CHAPTER 2: DESIGNATED MEDICAL DEVICE PERMIT

Section 26 specify the definition of designated medical device:The Minister may, from time to time, after taking into consideration the risk level of a medical device, the exposure of medical device to public health, patient safety and the degree of complexities of the medical device, specify a medical device to be a DESIGNATED MEDICAL DEVICE by an order published in the Gazette.

CHAPTER 2: DESIGNATED MEDICAL DEVICE PERMIT

Section 27(1) and (2) specify the requirement for designated medical device permit under the Act and the fine if the offence under subsection (1) is committed the definition of designated medical device:Section 27(1) No person shall use or operate any designated medical device unless the person holds a designated medical device permit granted under this Act. Section 15(2) Any person who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding one years or to both.

CHAPTER 3: DUTIES AND OBLIGATIONS OF LICENSEES OR PERMIT HOLDERS

Provide requirements for POST MARKET. Requirements are to be imposed to the establishment. Consist of 6 sections which specify provision on
Distribution records Post-market surveillance and vigilance Complaint handling Mandatory problem reporting Field corrective action Recall

CHAPTER 4: GENERAL DUTY

Provide requirements for post market but focusing on usage and marketing perspective. Requirements are to be imposed to the user and establishment. Consist of 2 sections which give provision on
Usage, operation, maintenance, etc., of medical device (Section 43) Advertising (Section 44)

CHAPTER 4: GENERAL DUTY

Section 43 specify the requirement on usage ,operation, maintenance of medical devices.
Section 43(1)
A person using or operating a medical device on a third party shall ensure that the medical device is: (a) Safe and efficacious (b) Used in accordance with its intended purpose (c) Used in accordance with the manufacturers instruction; and (d) Properly installed,tested, commissioned and maintained

Section 43(2) A person (a) Using or operating a medical device on a third party; or (b) installing,testing,commissioning,maintaining and disposing of a medical device shall have the qualification and competency as prescribed by the Minister. Section 43(3) A person using or opearting a medical device on a third party shall take the medical device out of operation when it is no longer safe and effective for use. Section 43(4) A medical device which has beed taken out out operation under subsection(3) shall be removed and disposed of in a safe manner.. Section43(6) Any person who contravenes subsection (1)(2)(3) or (4) commits an offence and shall, on conviction, be liable to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding one years or to both.

CHAPTER 4: GENERAL DUTY

Section 44 specify the requirement for advertising of medical device.
Section 44(1) No person shall advertise a medical device unless the medical device has been registered and complied with the requirements of this Act. Section 44(2) No person shall make any misleading or fraudulent claims in respect of a medical device in any advertisement. Section 44(3) Any person who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding three hundred thousand ringgit or to imprisonment for a term not exceeding three years or to both.

CHAPTER 5: EXPORT PERMIT

Provide requirements for export activities. Requirements are to be imposed to the establishment who do exportation. Consist of 2 sections which specify provision on:
Export permit (Section 45), Revocation of export permit (section 46).

MEDICAL DEVICE ACT (ACT 737) Part IV: Appeal

PART IV: APPEAL

The shortest part of the Act. Consist of 1 chapter which provides requirements for APPEAL against decision of authority on;
Registration, refusal or cancellation of medical device and conformity assessment body (sections 7, 9, 12 and 14), Grant, refusal, suspension or revocation of establishment licence (sections 22 and 24), Grant, refusal, suspension, revocation or renewal of designated medical device permit (sections 30, 33 and 35), Export permit and revocation of export permit (sections 45 and 46).

MEDICAL DEVICE ACT (ACT 737) Part V: Enforcement

PART V: ENFORCEMENT
Consist of 19 sections which provides requirements for enforcement activities including;
Power given to the Authority to carry out enforcement activities, Procedures on search and seizure with/without warrant, Accessibility to the information (eg. Computerized data), Cost recovering during enforcement activities, Power to require attendance of persons acquainted with case, arrest and take sample, Admission of statements in evidence, Appointment of analyst

MEDICAL DEVICE ACT (ACT 737) Part VI: General

PART VI: GENERAL

Consist of 14 sections which provides general requirements in relation to the provision of the Act. The provisions including,
Register, Confidential business information, Public disclosure, Emergency response plan and assistance from multi-agencies in emergency, Compounding of offences, Prosecution, Offence by body corporate, Offence by partner, agent or servant, Service of document False declaration, Power to exempt, General penalty, Regulations, Savings and transitional.

PART VI: GENERAL

The most important sections and applicable to the industry; Section 80 - Saving and transitional 1) A person who, prior to the appointed date, has imported, exported or placed in the market medical devices shall, within twenty four months from the appointed date, apply for registration of the medical devices under section 6.

PART VI: GENERAL

Section 80 - Saving and transitional 2) A person who, prior to the appointed date, has been importing, exporting or placing in the market medical devices and intend to continue importing, exporting or placing in the market such medical devices shall, within twelve months from the appointed date, apply for an establishment licence under section 16.

PART VI: GENERAL

Section 80 3) A person referred to in subsection (1) or (2) may continue to import, export or place in the market medical devices pending determination of its application for registration of medical device or for an establishment licence, as the case may be.

SUMMARY
Medical Device Act 2012 is intended to control medical device and its industry and to provide for matters connected thereto. It will be enforced on a date to be appointed by the Minister by notification in the Gazette. It also provide provision on transition period to assist industry and to ensure continuous accessibility of medical device for public use during the initial stage of implementation of the Act.

FOR YOUR ATTENTION.