2011/SOM1/SCSC/CON1/012 Session 7

Malaysias Experience in Regulating the Medical Device Sector

Submitted by: Malaysia

6th Conference on Good Regulatory Practice Washington, D.C., United States 1-2 March 2011

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Malaysiasexperiencein y p RegulatingtheMedical DeviceSector

TheMedicalDeviceControlDivision, The Medical Device Control Division MinistryofHealthMalaysia

Presentstatus:
There is no statutory premarket, placement on market,post market Except: requirements for the Radiation emitting devices e.g. registration and control of x-ray CT mammo ray, CT, medical devices before Act 304 enforced since they can be placed and 1974 used in Malaysia
RegulatorystatusinMalaysia

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ProblemswithMedicalDevice
Publichealth&safetyissues
Unavailabilityofpremarketcontroltoassesssafety, effectivenessandqualityofmedicaldevices ff ti d lit f di l d i Inadequateinformationforthepublicandhealth professionalstomakeinformedchoicesonmedicaldevices Lackofcontrolovertheusageofcertainmedicaldevices Nopostmarketreportingsystemtoidentifyandmonitor medicaldeviceswithproblemsinthemarket

F ilit ti Facilitatingmedicaldevicetrade&industry di l d i t d & i d t

Nofacilitationoflocalmanufacturerstomarkettheir productsglobally Nofavourableenvironmentforthegrowthofthemedical deviceindustry

WorldHealthOrganizationguidance
Governmentsneedtoputinplacepoliciesthatwill addressallelementsrelatedtomedicaldevices, rangingfromaccesstohighquality,affordable ranging from access to high quality affordable products,throughtotheirsafeandappropriateuse anddisposal. Policieswillbeunsuccessfulunlesstheyare translatedintonationalregulationsthatareenforced bylegislationandcorrelatingsanctions,andthatform anintegralpartoftheoverallnationalhealthsystem.

Source:Medicaldeviceregulations:Globaloverviewandguidingprinciples;WorldHealthOrganization,Geneva;2003 (At:http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf

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Background:CabinetDecision
16Feb2005:Cabinet approvedtheproposal todevelopMedical DeviceRegulatory PrograminMalaysia August2005: Establishmentof MedicalDevices Medical Devices Bureau
Development of MD Bill & subsidiary legislations Establishment of an organization to implement MD Regulatory Program Development of MD g Registration & Surveillance/ Vigilance System

PolicyObjectives
Toprotectpatientsandconsumers Toensuresafety,qualityandperformanceof medicaldeviceoverdevicelifecycle Tofacilitatetrade

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AimsoftheRegulation
Ensurepublichealth andsafety
Assuranceforsafetyand performance Timelyaccessfor beneficialmedical technologies Preventdumpingground forunsafeanddefective medicaldevices

Facilitatetradeand F ilit t t d d industry

Conduciveenvironment formedicaldevices manufacturing Facilitatetradeandexport Promotehealthtourism

Global Scenario in Medical Devices g Regulation

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Countries that currently regulate, or are in the process of developing regulations for, medical devices

Canada

EU

United States Cuba

Slovenia Turkey Slovakia

Japan China Israel India Thailand y Malaysia Indonesia South Africa Australia New Zealand South Korea Hong Kong g Chinese Taipei Philippines

Colombia Peru Chile Brazil Argentina Uruguay Venezuela

*29 Members

GHTF Founding Member

Regulations in Other Countries - Laws &

authorities for medical devices
US Laws/regulations Regulatory authority Center for Devices & Safety Medical Devices Act Radiological Health, FDA Medical Devices User Fee & Modernization Act Code f Federal Register Part C d of F d l R i t P t 800 900 Medical Devices Regulation 2002 under Consumer Medicines & Healthcare Protection Act 1987 Products Regulatory Agency Therapeutic Goods Act 1989 Office of Devices, Blood & Tissue, TGA Therapeutic Goods (Med Devices) Regulations 2002 Medical Devices Bureau, Food & Drug Act Therapeutic Product Medical Devices Regulations (No 1101) Directorate Medical Devices Regulations (No 1162) Amendment Medical Devices Regulations (No 1293) Quality System Pharmaceutical Affair Law Ministry of Health, Labour & Welfare Pharmaceutical Control Law Cabinet Orders & Ministerial Ordinances General regulations, has not had in place documents Medical Devices & Radiation providing details for approvals specific to products Health Dept, Korean FDA Regulatorystatusinvariouscountries

UK Australia Canada

Japan

Korea

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Regulations in Other Countries - Laws &

authorities for medical devices
New Zealand China Laws/regulations Medicines Act 1981 Medicines (Database of Medical Devices) Regulations 2003 The Regulation on Supervision & Administration of Medical Devices Regulatory authority Medicines & Medical Devices Safety Authority State Drug Administration State Admin for Technical & Quality Supervision State Admin for Entry/Exit Inspection & Quaratine Medical Device Control Division, Thai FDA Bureau of Health Devices & Technology, Dept of Health Center for Medical Device Regulation, HSA Directorate of Medical Device Production & Distribution MoH Regulatorystatusinvariouscountries

Thailand Philippines Singapore Indonesia

Medical Device Act 1988 Ministerial Regulations 1 7 Law governing medical devices is being drafted Health Products Act Medical Devices Regulations Health Law No 23 1992

Harmonizationwiththe GlobalHarmonizationTaskForce Recommendations(GHTF)

Medicaldevicesshouldbedesignedandmanufacturedin suchawaythat,whenusedundertheconditionsandfor thepurposesintendedandwhereapplicable,byvirtueof thetechnicalknowledge,experience,educationortraining ofintendedusers,theywillnotcompromisetheclinical conditionorthesafetyofpatients,orthesafetyofhealth ofusersor,whereapplicable,otherpersons,providedthat anyriskswhichmaybeassociatedwiththeiruseconstitute i k hi h b i t d ith th i tit t acceptableriskswhenweighedagainstthebenefitstothe patientandarecompatiblewithahighlevelofprotection ofhealthandsafety (EssentialprinciplesofsafetyandperformanceofmedicaldevicesrecommendedbyGHTF
(SG1NO20R5)

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GuidingPrinciples
Theprimarygoalistoprotectpublichealthandsafety Th l l f Thelevelofregulatorycontrolshouldbeproportionalto l l h ld b i l thedegreeofrisk Expeditestimelyavailabilityandaccesstosafeand beneficialmedicaldevicesandtopreventunsafeand ineffectivemedicaldevicesfromenteringthemarket Elementsofcontrolfromdesignthroughdisposalstages shallbeputinplacetoensurecontinuedsafetyand shall be put in place to ensure continued safety and quality Inlinewithglobalharmonizationefforttominimize regulatorybarriers,facilitateinternationaltrade, improveaccesstonewtechnologiesandtoreducethe costofimplementingregulation

FrameworkoftheMalaysian Frameworkofthe Malaysian

MEDICALDEVICE REGULATORYSYSTEM REGULATORY SYSTEM

MedicalDevicesBureau
MINISTRY OF HEALTH MALAYSIA

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Survey the usage and inventory Establish Policy Directions

Act Regulations

Input from all stakeholders

Guidance Notes/ Code of good practices Standards Registration and Vigilance system

Resources Allocation

Implement control and enforcement ActionPlan TheMedicalDeviceRegulatoryFramework

RegulatoryFramework
Definitionofamedicaldevice Premarketrequirements Requirementsforplacementonthe market Postmarketrequirements Enforcementandinvestigation

MedicalDevicesBureau
MINISTRY OF HEALTH MALAYSIA

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Definition
Rangeofmedical devices Widearrayofproducts withmyriaduses Complexityfrom simpletosophisticated
system

Global market place: Globalmarketplace:

Coverawidespectrum ofrisk,whilstproviding benefittopatients

400,000differentmedical deviceproductsinsome 10,000productcategories

MedicalDevices
Active Medical Device Diagnostic Therapeutic Others (Non-Active) Implantable Medical Device

Non-Invasive

Invasive

Class A

Class B

Class C

Class D
ENGINEERING SERVICES DIVISION MINISTRY OF HEALTH

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Definition
Whatisamedicaldevice? Medicaldeviceisanyinstrument,apparatus,implement,machine, appliance,implant,invitro reagentorcalibrator,software,materialorother similarorrelatedarticle: similar or related article: a) intendedbythemanufacturertobeused,aloneorincombination,for humanbeingsforoneormoreofthespecificpurposesof:
diagnosis,prevention,monitoring,treatmentoralleviationofdisease; compensationforaninjury; investigation,replacement,modification,orsupportoftheanatomyorofa physiologicalprocess; supportingorsustaininglife; controlofconception; disinfectionofmedicaldevices; di i f ti f di l d i providinginformationformedicalordiagnosticpurposesbymeansofinvitro examinationofspecimensderivedfromthehumanbody;

and b) whichdoesnotachieveitsprimaryintendedactioninoronthehuman bodybypharmacological,immunologicalormetabolicmeans,but whichmaybeassistedinitsintendedfunctionbysuchmeans

MedicalDevicesBureau
MINISTRY OF HEALTH MALAYSIA

Definition

AMedicalDevice regulatoryprogram appliestoallmedical devicesonthe Malaysianmarket Malaysian market

Whatisamedicaldevice? Thetermmedicaldevice coversanyproductsused inhealthcareforthe diagnosis,prevention, monitoringortreatment ofillnessorhandicapbut excludesdrugs

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Risk Risk BasedClassificationfor RegulatoryControl

Medical device is classified based on the risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device Risk-based classification;
-

Riskbasedclassification& regulatorycontrol
Regulatory yrequirements

Class A (low) Class B (low moderate) Class C (high moderate) Class D (high)

Regulatory control should be proportional to the level of risk associated with a medical device

Devicerisk

Risk Risk BasedClassification& RegulatoryControl

Class A Risk Level Low Device examples Simple surgical instruments, tongue depressor, liquid-in-glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes, walking aids Hypodermic needles, suction equipment, anaesthetic breathing circuits, aspirator, external bone growth simulators, hearing aids, hydrogel dressings, patient controlled pain relief, phototherapy unit, xray films Lung ventilator, orthopaedic i l t b b i b t bl d L til t th di implants, baby incubator, blood oxygenator, blood bag, contact lens disinfecting/cleaning products, deep wound dressing, defibrillator, radiological therapy equipment, ventilator Pacemakers and their leads, implantable defibrillators, implantable infusion pumps, heart valves, inter-uterine contraceptive devices, neurological cathethers, vascular prostheses and stents

LowModerate

HighHi h Moderate

High

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Scopeofregulation
PREMARKET PRE MARKET PLACEMENT PLACEMENT ONMARKET
Distribution Supply Advertising

POSTMARKET POST MARKET

Design&development Manufacture,import/ export Packaging,labeling, storage t

Surveillance&vigilance Installation,T&C, maintenance,calibration, repairs O Operation,usage ti Decontamination, decommission,disposal

PreMarketRequirements
Whatarethe processes carriedoutto ensurethata medicaldevice issafe,quality issafe,quality s sa e, qua ty &performas intendedfor?
DefinetheMedicalDevice Classifyaccordingtorisks Meetstheessentialprinciples Manufacturedaccording manufacturing principles manufacturingprinciples Labeling,packaging,marking Carryout Conformityassessment

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PostMarketRequirements
Definethe requirements to be requirementstobe fulfilledto.Howto, continuously monitorsafetyand performanceof medicaldeviceson medical devices on themarket
takecorrectiveactions onanyproblemsrelated tomedicaldeviceson themarket Surveillanceand VigilanceSystem DistributionRecords ComplaintsHandling MandatoryReporting Mandatory Reporting FieldCorrection Recall

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OverviewofTheRegulatorySystem
PRE-MARKET PLACEMENT ON-MARKET POST-MARKET

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

MEDICAL DEVICES REGISTRATION Manufacturers (or LARs) apply for 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 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

SURVEILLANCE & VIGILANCE Establishments shall monitor safety & performance of their products carry out post-market obligations, eg user training, complaint handling, FSCA, recall USAGE & MAINTENANCE Users shall use, maintain & dispose off medical devices appropriately Users shall apply for permit to use/operate designated medical devices

CAB verifies evidence of conformity

MDA monitors compliance to requirements & takes appropriate actions in accordance with the provisions of the law

EssentialPrinciplesofSafety& Performance
Amedicaldeviceshall conformtoessential requirementsofsafety andperformance

EssentialRequirementsof Safety&Performanceof MedicalDevices 6generalrequirements 11design&manufacturing 11 d i & f i requirements

GHTF/SG1/N41R9:2005:EssentialPrinciplesofSafety& PerformanceofMedicalDevices

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EssentialPrinciplesofSafety& Performance
1) Nocompromiseonclinical conditionandsafetyofpatients,healthand safetyofusersandotherpersonswhenuseundertheconditionsandfor thepurposesintended the purposes intended 2) Inthedesignandconstructionofmedicaldevice,hazards,associatedrisks andforeseeablemisusefromtheintendeduseshouldbeidentified, eliminated/reduced;anyresidualrisksthatcannotbeeliminated, protectionmeasuresshouldbetakenandshouldbeinformedtousers 3) Medicaldeviceshouldachievetheintended/specifiedperformanceand bedesigned,manufacturedandpackedinsuchawaythatitissuitablefor thefunctionswithinthescopeofthedefinitionofmedicaldevice 4) Characteristicsandperformancesshouldnotbeadverselyaffectedby stressesduringnormalconditionsofuseandpropermaintenance d l d f d 5) Characteristicsandperformancesduringtheintendeduseshouldnotbe adverselyaffectedundertransportandstorageconditions 6) Thebenefitsoutweighanyundesirablesideeffects

Back

EssentialPrinciplesofSafety& Performance
1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) Chemical,physicalandbiologicalproperties Infectionandmicrobialcontamination Manufacturingandenvironmentalproperties f i d i l i Deviceswithadiagnosticormeasuringfunction Protectionagainstradiation Requirementsformedicaldevicesconnectedtoorequippedwithan energysource Protectionagainstmechanicalrisks Protectionagainsttherisksposedtothepatientbysuppliedenergyor substances Protectionagainsttherisksposedtothepatientfordevicesforself testingorselfadministration Informationsuppliedbythemanufacturer Performanceevaluationincluding,whereappropriate,clinicalevaluation
MedicalDevicesBureau
MINISTRY OF HEALTH MALAYSIA

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Who&WhatwillbeRegulated?
Responsible parties Local manufacturers Regulated activities/responsibilities To ensure products meet essential principles of safety & performance (EPSP) and are manufactured in accordance with good manufacturing practice (GMP) To apply for product registration To monitor safety & performance and to take corrective actions on problems related to products in the market To act on behalf of foreign manufacturers with regard to the manufacturers responsibilities under the Malaysian laws To ensure compliance with requirements of good distribution practice (GDP), eg cleanliness & suitability of premises, storage & stock handling, traceability, product complaints, etc To verify evidence of conformity to EPSP, GMP, GDP To ensure competencies of users & persons involve in maintenance of medical devices To apply for permit to use designated medical devices

Exporters

Local authorized representatives (LARs) of foreign manufacturers Importers Distributors Conformity assessment bodies (CABs) Users of medical devices on patients

Coordinationwith Stakeholders

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EssentialPrinciplesofSafety& Performance
Chemical,physicalandbiologicalproperties Infectionandmicrobialcontamination Manufacturingandenvironmentalproperties Deviceswithadiagnosticormeasuringfunction Protectionagainstradiation Requirementsformedicaldevicesconnectedtoorequippedwith anenergysource 7) Protectionagainstmechanicalrisks ) g p p y pp 8) Protectionagainsttherisksposedtothepatientbysupplied energyorsubstances 9) Protectionagainsttherisksposedtothepatientfordevicesfor selftestingorselfadministration 10) Informationsuppliedbythemanufacturer 11) Performanceevaluationincluding,whereappropriate,clinical evaluation
Back

1) 2) 3) 4) 5) 6)

Empowerment
EmpowertheindustrytoselfdeclareforClassA devices Manufacturerthemselveschoosetheregulatory controlrouteofmedicaldevicesthey manufacturebasedontheriskclassification Abridgesystem,wherebyproductscanbe registeredeasilyiftheyhavebeenapprovedby registered easily if they have been approved by the5foundingmembersoftheGHTF. ConformityAssessmentsarecarriedoutbya thirdparty

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Risk Risk BasedRegulatoryControl

Regulatorycontrolisproportionaltothelevelofriskassociatedwithamedicaldevice Technical Prepare tech document documentation Prepare tech document Submit for review Establish PMS Maintain PMS Prepare tech document Submit for review Establish, maintain PMS Make available for audit Establish, maintain full QMS Make available for audit Prepare, sign & submit Class C Prepare tech document Submit for review Establish, maintain PMS Make available for audit Establish, maintain full QMS Make available for audit Prepare, sign & submit Class D

Regulator requirements ry

Post-market Establish PMS surveillance Maintain PMS system (PMS) Quality mgmt Establish & maintain QMS system (QMS) excl design requirement Declaration of Prepare, sign & submit conformity Class A

Establish & maintain QMS excl design requirement Prepare, sign & submit Class B

Medical device class/risk

TheUseofHarmonizedStandards
To demonstrate conformance to essential principles of safety and performance To demonstrate conformance to management and manufacturing standards P Promoting ti harmonization by adopting international standards The use of standards p helps in
improving productivity improving market competitiveness improving export capability reducing cost

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ThankYou

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