medical device act 2012 (act 737) - mda

Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA

MEDICAL DEVICE ACT 2012 (ACT 737)

IR.SASIKALA DEVI THANGAVELU

MEDICAL DEVICE AUTHORITY

MALAYSIA,


• Background

• Medical Devices Regulatory System

• Medical Device Authority Act 2012 (Act 738)

• Medical Device Act 2012 (Act 737) − Part I – Preliminary

− Part II: Registration Of Medical Device And Conformity Assessment Body

− Part III: License and Permit

− Part IV: Appeal

− Part V: Enforcement

− Part VI: General

• Summary

CONTENT

BACKGROUND

The Engineering Services Division, Ministry of Health (MoH) initiated development of medical device regulation since 2003

16 Feb 2005: Cabinet approved the proposal to develop Medical Device Regulatory Program in Malaysia

August 2005: Establishment of Medical Devices Control Division

14 June 2012: Establishment of Medical Device Authority

Development of MD Bill &

subsidiary legislations

Establishment of an organization

to implement MD Regulatory

Program

Development of MD Registration

& Surveillance/ Vigilance System

MEDICAL DEVICES AUTHORITY MALAYSIA . http://www.mdb.gov.my

http://www.mdb.gov.my/


MEDICAL DEVICE REGULATION : OBJECTIVES

• To address public health & safety issues • pre-market control to assess safety, effectiveness and

quality of medical devices

• adequate information for the public and health professionals to make informed choices on medical devices

• control over the usage of certain medical devices

• post-market reporting system to identify and monitor medical devices with problems in the market

• To facilitate medical device trade & industry • To facilitate our local manufacturers to market their

products globally

• To provide a favourable environment for the growth of medical device industry




MEDICAL DEVICE REGULATION: HARMONISATION

• Definition of medical device

• WHO Regulatory model

• Risk Based Classification

• Essential Principles of Safety & Performance of Medical Device (EPSP) is based on GHTF.

• CSDT

• ASEAN Medical Device Directive (AMDD)

1 - Global Harmonization Task Force (www.ghtf.org)



MEDICAL DEVICES REGULATION: REGULATORY FRAMEWORK IN MALAYSIA:

Stages of Regulatory Control throughout the life cycle of medical device

WHO Regulatory Model



USAGE & MAINTENANCE

• Users shall use, maintain &

dispose off medical devices

appropriately

• Users shall apply for permit to

use/operate designated medical

devices

SURVEILLANCE & VIGILANCE

Establishments shall-

• monitor safety & performance of

their products

• carry out post-market

obligations, eg user training,

complaint handling, FSCA,

recall

M

MDA allows -

• registered

medical

devices to be

placed into the

market

• licensed

establishments

to do their

business

MEDICAL

DEVICES WILL

BE MADE

AVAILABLE

ON THE

MARKET

THE REGULATORY FRAMEWORK

PRE-MARKET REVIEW

Manufacturers of medical

devices shall -

• ensure their products

conform to EPSP

• ensure their products are

manufactured in accordance

with GMP

• collect evidence of

conformity

PRE-MARKET PLACEMENT ON-MARKET POST-MARKET

MEDICAL DEVICES

REGISTRATION

• Manufacturers (or LARs)

apply to register medical

devices & establishment

license to manufacture

DISTRIBUTORS

LICENSING

Distributors shall -

• ensure compliance to

GDP & advertising

requirements

• apply for establishment

license to distribute

medical devices

MDA monitors compliance to requirements & takes appropriate

actions in accordance with the provisions of the law

MANUFACTURER/AUTHORISED REPRESENTATIVE [AR]/

IMPORTER/ DISTRIBUTOR-ESTABLISHMENT

MANUFACTURER/

AR

HEALTHCARE INSTITUTION


MEDICAL DEVICE ACT & MEDICAL DEVICE AUTHORITY ACT

INSTITUTIONAL

STRUCTURE……


STRUCTURE OF MEDICAL DEVICE

REGULATORY SYSTEM

• Medical Device Act 2012 (Act 737) − To regulate medical devices, the industry and to

provide for matters thereto


• Medical Device Authority Act 2012 (Act 738) − To provide for the establishment of the Medical Device

Authority with powers to control and regulate medical

device, its industries and activities, and to enforce the

medical device laws, and for related matters


Chief Executive, officers,

servants

MEDICAL DEVICE AUTHORITY

MINISTER OF HEALTH

MEDICAL DEVICE REGULATORY SYSTEM:

INSTITUTIONAL STRUCTURE

MEDICAL DEVICE

AUTHORITY 2012

(Act 738)

MEDICAL DEVICE ACT

2012 (Act 737) &

subsidiary legislations

CABs

Establishments

•Manufacturers

•ARs

•Distributors

•Exporters

Users

.. gives p

ow

ers to

…

.. give p

ow

ers to

…




IMPORTANT REGULATORY ACTIVITIES


IMPORTANT REGULATORY ACTIVITIES

•Medical device registration under Section 5 Act 737

•Establishment licensing under Section 15 Act 737


•Manufacturer

− To ensure medical devices meet EPSP and

are manufactured in accordance with good

manufacturing practice

− To apply for registration

•Authorized representative

− To ensure compliance with requirements of

good distribution practice (GDPMD)

− To monitor safety & performance and to take

appropriate corrective/preventive actions

− To act on behalf of foreign manufacturers

with regard to the manufacturer’s

responsibilities under Act 737

•Importer and distributor

− To ensure compliance with requirements of

good distribution practice (GDPMD)

Types of “establishment” •Manufacturer

•Authorized representative

•Importer and distributor


RISK--BASED CLASSIFICATION & REGULATORY CONTROL

• Medical device is classified based on the risk associated with the vulnerability of the human body ,design and manufacture design

• Risk-based classification;

− Class A (low)

− Class B (low moderate)

− Class C (high moderate)

− Class D (high)

• Regulatory control is proportional

to the level of risk associated with a

medical device


MEDICAL DEVICE ACT (ACT 737)


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.


“MANUFACTURER”

(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: (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


AUTHORIZED REPRESENTATIVE

• “authorized representative” means a person or a firm or company constituted under the laws of Malaysia, and carrying on business or practice principally in Malaysia appointed by a manufacturer having a principal place of business outside Malaysia to deal with any regulatory matters under the Act


DISTRIBUTOR

• “distributor” means any natural or legal person in the supply chain who, on his own behalf, places a medical device on the market and further the availability of the medical device to the end user including persons in the supply chain involved in activities such as storage and transport on behalf of the authorized representative, importer or distributor;

• “distribution” means the activities of pre (release), placement (delivery) and post-delivery of medical devices conducted by the establishment


IMPORTER

• “importer” means any natural or legal person in the supply chain who imports a medical device into Malaysia

• “import” means to bring or cause to be brought a medical device manufactured in another country or jurisdiction, into Malaysia by land, sea or air;


PLACE IN THE MARKET

• “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 performance evaluation of a medical device


MEDICAL DEVICE (SECTION 2, ACT 737)

“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) diagnosis, monitoring, treatment, alleviation of or

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;




MEDICAL DEVICE (SECTION 2, ACT 737)

(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;

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.



RISK-BASED CLASSIFICATION Class Risk Level Device examples

A Low Simple surgical instruments, tongue depressor, liquid-in-glass

thermometer, examination light, simple wound dressing, oxygen mask,

stethoscopes, walking aids,examination lights,hospital bed,examination

gloves, stethoscope,, wheelchair(non powered)

B Low-

Moderate

Hypodermic needles, suction equipment, anaesthetic breathing circuits,

aspirator, external bone growth simulators, hearing aids, hydrogel

dressings, patient controlled pain relief, phototherapy unit, x-ray

films,ECG,EEG,contact lenses,MRI,surgical gloves

C High-

Moderate

Lung ventilator, orthopaedic implants, baby incubator, blood oxygenator,

blood bag, contact lens disinfecting/cleaning products, deep wound

dressing, defibrillator, radiological therapy equipment, ventilator, X-

Ray,HDU,infusion pump, surgical laser, linac

D High Active implantable devices,Pacemakers and their leads, implantable

defibrillators, implantable infusion pumps, heart valves, inter-uterine

contraceptive devices, neurological cathethers, vascular prostheses and

stents,Anaesthetic devices, stent,


MEDICAL DEVICE ACT (ACT 737) PART II: (REGISTRATION OF MEDICAL DEVICE

AND CONFORMITY ASSESSMENT BODY)


MEDICAL DEVICE REGISTRATION

Who register medical device??

• Manufacturer

• Authorized Representative


HOW REGISTRATION IS DONE?

Assessment on

• CSDT

• PMAS

• DOC

• QMS

Yes

No

MMMM

Complied with

registration

requirements ?

MEDICAL

DEVICE

REGISTER

FEE

• AR

• Manufacturer

MDA ESTABLISHMENT CONFORMITY

ASSESMENT BOBDY

Application forms

DoC

Cert QMS (ISO 13485)

CSDT

PMAS

DoC

PMAS

QMS

CSDT

CAB Report

MEDICAL DEVICE REGISTRATION


REQUIREMENTS FOR REGISTRATION OF MEDICAL DEVICE

Section 5: 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

− 5(2): Fine for offence under subsection (1) – RM200K or 3 years or to both

MEDICAL DEVICE REGISTRATION CERTIFICATE


MEDICAL DEVICE ACT (ACT 737) PART III: (LICENCE AND PERMIT)


CHAPTER 1: ESTABLISHMENT LICENCE

Section 15(1) and (2) gives provision on the requirement for establishment licensing 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.”

LICENSING OF ESTABLISHMENTS

Establishment means an “establishment” as defined in S2 Act 737 who is either a manufacturer, authorized representative (of foreign manufacturer), importer or distributor of medical devices

Establishment must possess valid license to carry out activities related to medical devices in Malaysia Imported medical

device

Importer

Authorized representative

Foreign manufacturer

Distributor

Local manufacturer

Distributor

Types of establishments

Locally-made

medical device

Assesment

• QMS based on

MDR III Schedule

Yes

No

MMMM

Complied with

Licensing

requirements ?

MEDICAL

DEVICE

REGISTER

FEE

• AR

• Manufacturer

• Distributor

• Importer

MDA ESTABLISHMENT CONFORMITY

ASSESMENT BODY

(CAB)

Documentation

ISO13485 or GDPMD

PMS

Attestation for

establishment licensing

application

PMS

QMS

Authorisation letter

List of MD

Report

Certificate of conformity

LICENSING OF ESTABLISHMENT


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

ESTABLISHMENT LICENCE


CHAPTER 4: GENERAL DUTY



• Provide requirements for post market but focusing on usage and marketing perspectives.

• 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)



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 manufacturer’s 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 operating 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 been taken 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.”



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

• Consist of 2 sections which specify provision on:

− Export permit (Section 45),

− Revocation of export permit (section 46).



PART IV: APPEAL



PART V: ENFORCEMENT


PART V: ENFORCEMENT

Consist of 19 sections( S48-S66) 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



PART VI: GENERAL


PART VI: GENERAL (SECTISECTION 67: REGISTER ON 67-80)

Authority shall maintain a register:

(a) All medical devices registered under this Act

(b)All CAB registered under this Act

(c) All licenses and permits granted by authority

(d) All decision by Authority to cancel registration of medical devices or CAB

(e) All decisions of authority to revoke and suspend licenses or permits

(f) any other matters or data as may be specified by the


SECTSECTION 80 - SAVING AND TRANSITIONAL

ION 80: SAVINGS 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.

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.

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.


TRANSITION

• Effective date of Act 737: 1 July 2013

• Establishment license: 12 months from effective date, 1 July 2014

• Medical device registration: 24 months from effective date, ie 1 July 2015

• Exemption of Registration: 1 July 2015-1 July 2016

TIMELINE

1 July 2015-1 July 2016-Exemption of Registration

I July 2013- 1 July 2015 : Transitional Period for Registration of Medical Devices

1 July 2013 : 1 July 2014 : Transitional period for Licensing of Establishment

1 July 2013 : Effective date of MDR 2012

30 June 2013 : Effective date of Act 737

14 June 2012 : Establishment of Medical Device Authority


SUMMARY

REGULATORY FRAMEWORK

PRE-MARKET PLACEMENT ON- MARKET POST-MARKET

S4 Act 737 Reg 4

3rd Schedule MDR2012:

Manufacturer shall ensure its medical device •conforms to EPSP •Is appropriately packaged & labelled •Manufactured QMS •Collect evidence of conformity

S15-25 Act 737 Reg 11-15 3rd Schedule MDR2012 •Manufacturer, AR, importer and

distributor shall apply for

establishment license

•AR, importer or distributor

shall comply with GDPMD

S37-42 Act 737: Establishment shall monitor

safety & performance of its

medical device and carry out

post-market obligations

S26-36 & S43 Act 737

•User shall apply for permit

to use/operate designated

medical devices

•User shall use, maintain &

dispose off medical devices

appropriately

S5 -9 Act 737 Reg 5-7 & 11-15

3rd Schedule MDR2012:

•Manufacturer or AR shall

apply for medical device

registration

•MDA evaluates application

for medical device registration

S10 - S14 Act 737 Reg. 8-10 4th Schedule MDR2012 •MDA evaluates application for CAB registration •CAB conducts conformity assessment

S44 Advertisement S45-46 Export permit S47 Appeal S48-79 Act 737: MDA monitors compliance & takes appropriate actions

S80 Act 737 Saving and transitional

General principles

Medical device should be designed & manufactured in such a way that:

1. no compromise to clinical condition or safety of patients, or safety and health of users or other persons

2. control the risk so that residual risk is brought down to an acceptable level

3. suitable for one or more of the functions within the scope of the definition of a medical device

4. characteristics and performances should not be adversely affected to such a degree that they compromise the health or safety of patient or user and other persons during the lifetime of the device

5. characteristics and performances during their intended use will not be adversely affected under transport and storage conditions

6. benefits must be determined to outweigh any undesirable side effects

Design and manufacturing principles

1. Chemical, physical and biological properties

2. Infection and microbial contamination

3. Manufacturing and environmental properties

4. Devices with a diagnostic or measuring function

5. Protection against radiation

6. Requirements for medical devices connected to or equipped with an energy source

7. Protection against mechanical risks

8. Protection against the risks posed to the patient by supplied energy or substances

9. Protection against the risks posed to the patient for devices for self-testing or self- administration

10. Information supplied by manufacturer

11. Performance evaluation including where appropriate, clinical evaluation

Essential Principles of Safety & Performance of Medical Device

CONFORMITY ASSESSMENT Reg4 MDR 2012: 3rd Schedule

medical device act 2012 (act 737) - mda

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