introduction to medical act 2012_act 737_moh presentation

7/31/2019 Introduction to Medical Act 2012_Act 737_MOH Presentation

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World Health Organization Guidance

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

Policies will be unsuccessful unless they are translated into nationalregulations 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 guidingprinciples; World Health Organization, Geneva; 2003

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


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INTRODUCTION TOMEDICAL DEVICE ACT 2012

(ACT 737)

IDAMAZURA IDRIS @ HARUNMEDICAL DEVICE CONTROL DIVISION, MINISTRY OF HEALTH

LEVEL 5, MENARA PRISMA, PERSIARAN PERDANA PRECINCT 3, PUTRAJAYA


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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


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BACKGROUND

16 Feb 2005: Cabinetapproved the proposalto develop MedicalDevice RegulatoryProgram in Malaysia

August 2005:Establishment of

Medical DevicesControl Division

Development of MD Bill &

subsidiary legislations

Establishment of an

organization to implement MD

Regulatory Program

Development of MD

Registration & Surveillance/

Vigilance System

MEDICAL DEVICES CONTROL DIVISION, Ministry of Health Malaysia


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MEDICAL DEVICE REGULATORY

FRAMEWORK


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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 professionalsto 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


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Harmonised

medical device regulation

Definition-GHTF/WHO

Risk Based ClassificationGHTF

Risk Based Regulation

Regulatory ModelWHO Model


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MEDICAL DEVICES REGULATORY

FRAMEWORK IN MALAYSIA:

W.H.O. REGULATORY MODEL-life cycle

Stages of Regulatory Control


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Participants in ensuring the safetyof medical device

DISTRIBUTOR/

IMPORTER

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


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MEDICAL DEVICES ACT 2012

ACT 737


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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.


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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.


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MEDICAL DEVICE ACT (ACT 737)

Long title:

An Act to regulate medical devices, the

industry and to provide for matters connectedthereto.

It is enacted by the Parliament.


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Part I: Preliminary


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PART I: PRELIMINARY

This part provides the short title andcommencement of the Act and interpretation.

Section 1(1) This Act may be cited as the MedicalDevice Act 2012.

Section 1(2) This Act comes into operation on adate to be appointed by the Minister by notificationin the Gazette.

Section 2 provides interpretation of terminologiesused in this Act.

Interpretations specify the scopes of the Act.


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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 manufacturerhaving 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


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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 finishedproduct meets the regulatory requirement; or



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(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 productmeets 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



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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 ofin vitro

examination of specimens derived from the human body;



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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.



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Part II: Registration Of Medical

Device And

Conformity Assessment Body


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Provides requirements for registration.

Consist of 2 chapters;

i. Chapter 1: Registration of medical device (fromsection 3 up to section 9)

ii. Chapter 2: Registration of Conformity Assessment

Body (from section 10 to section 14)

PART II:

REGISTRATION OF MEDICAL DEVICE AND

CONFORMITY ASSESSMENT BODY


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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 tovary or revoke conditions

Section 9: Power to cancel registration of medical device


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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 ofdispute between an establishment and a

conformity assessment body, the classification can be

referred to the Authority for its decision in mannerspecified in section 3(2).


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MEDICAL DEVICE

Section 4 specify manufacturers obligation to ensure amedical 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.


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MEDICAL DEVICE

Section 5 specify the requirement for medical deviceregistration before the device can be marketed.

Section 5(1)

No medical device shall be imported, exported or placed inthe 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.


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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


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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 (Sub-

section (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 (Sub-

section (5)).


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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.


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Part III: Licence and Permit


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PART III: LICENCE AND PERMIT

Chapter I: Establishment licence

Chapter 2: Designated Medical Device Permit

Chapter 3:Duties and obligation of licenseesor permit holders

Chapter 4: General Duty

Chapter 5: Export permit


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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


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CHAPTER 1: ESTABLISHMENT LICENCE

Section 15(1) and (2) gives provision on therequirement 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.


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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


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Section 31: Power to impose additional conditions and to varyor 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 non-

renewal of designated medical device permit

CHAPTER 2: DESIGNATED MEDICALDEVICE PERMIT


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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.


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Section 27(1) and (2) specify the requirement fordesignated medical device permit under the Act andthe fine if the offence under subsection (1) iscommitted the definition of designated medical

device:-Section 27(1)

No person shall use or operate any designated medical device unless theperson 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 thousandringgit or to imprisonment for a term not exceeding one years or to both.


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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


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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


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CHAPTER 4: GENERAL DUTYSection 43 specify the requirement on usage ,operation, maintenance of medicaldevices.

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 ofoperation 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 ofin a safe manner..

Section43(6)

Any person who contravenes subsection (1)(2)(3) or (4) commits an offence and shall, on conviction, be liableto a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding one years orto both.


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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 medicaldevice has been registered and complied with the requirements ofthis Act.

Section 44(2)

No person shall make any misleading or fraudulent claims in respectof a medical device in any advertisement.

Section 44(3)

Any person who contravenes subsection (1) commits an offence andshall, on conviction, be liable to a fine not exceeding three hundredthousand ringgit or to imprisonment for a term not exceeding threeyears or to both.


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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).


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Part IV: Appeal


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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 and14),

Grant, refusal, suspension or revocation ofestablishment licence (sections 22 and 24),

Grant, refusal, suspension, revocation or renewal of

designated medical device permit (sections 30, 33 and35),

Export permit and revocation of export permit (sections45 and 46).

PART IV: APPEAL


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Part V: Enforcement


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Consist of 19 sections which providesrequirements for enforcement activities including; Power given to the Authority to carry out enforcement

activities,

Procedures on search and seizure with/withoutwarrant,

Accessibility to the information (eg. Computerizeddata),

Cost recovering during enforcement activities,

Power to require attendance of persons acquaintedwith case, arrest and take sample,

Admission of statements in evidence,

Appointment of analyst

PART V: ENFORCEMENT


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Part VI: General


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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


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PART VI: GENERAL

The most important sections and applicable tothe 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, applyfor registration of the medical devices under

section 6.


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PART VI: GENERAL

Section 80 - Saving and transitional2) A person who, prior to the appointed date,

has been importing, exporting or placing in

the market medical devices and intend tocontinue 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.


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PART VI: GENERAL

Section 803) A person referred to in subsection (1) or (2)

may continue to import, export or place in

the market medical devices pendingdetermination of its application for

registration of medical device or for an

establishment licence, as the case may be.


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SUMMARY

Medical Device Act 2012 is intended to controlmedical device and its industry and to provide formatters connected thereto.

It will be enforced on a date to be appointed bythe Minister by notification in the Gazette.

It also provide provision on transition period toassist industry and to ensure continuous

accessibility of medical device for public useduring the initial stage of implementation of theAct.


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introduction to medical act 2012_act 737_moh presentation

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