medical device authority malaysia 22th november 2013 · surgical instruments, implants &...
TRANSCRIPT
Medical Device Authority
Malaysia
22th November 2013
Malaysian Market
• Malaysia currently imports around 95% of the medical device for its consumption especially on active devices
• The medical devices industry :-
– highly diversified industry that produces a broad range of products and equipment ranging from medical gloves, implantable devices, orthopaedic devices and dialysers to diagnostic imaging equipment and minimal invasive surgical equipment and other devices which can be used for medical, surgical, dental, optical and general health purpose.
The Industry in Malaysia
• 190 small to large players in the country –
(manufacturing, distribution, sales )
• Export revenues of RM 11.7 Billion in 2011
• Export CAGR of 10 % per annum from 2000 – 2011
• Dominated by MNCs and local latex glove manufacturers
Source: AMMI
9.4 2.32.3
28%
12%
13%
12%
12%
11%5%7%
Reusable instruments
Radiation devices
Opthalmic
Catheters, syringes, needles &
sutures
Contraceptives
Electro mechanical MDOrthopedic implants
Others
Malaysia
Exports of Medical Devices
RM
Billion
RM
Billion
GlovesMedical
Devices
(Excluding
Gloves)
Source: Malaysia Statistics Department, MITI, MIDA, PEMANDU
Total Exports in 2011: RM11.7 Billion
ConsumablesSurgical Instruments,
Implants & Clinical Devices
Healthcare
Equipment
TechnologyLatex
PlasticMetal Machining Implants IVDs, others
Products
Companies
Supporting Infrastructure
Sterilization CertificationPackagingBiocompatibility
And Clinical Trial
Materials: Rubber, Plastics, Steel, Electronics, etc.
Industry
Group
Education
TrainingRegulatory
Glove, Contraceptives,
Catheters, woundcare,
Orthalmology,
Pacemaker, Orthopedics,
Surgical instrument
Radiation equipment, IVDs,
Life Science Instrument,
Electrodes, Hospital beds
UKM, UM, USM, UKM,
UniMap, PSDC,
Medsociate,
Neville Clarke
Medical
Device
Act 2012
Medical Device Industry Ecosystem in Malaysia
Info
Kinetics
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 to 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 )
Philippines
Mexico
Australia
CONCEPTUAL QUALITATIVE OVERVIEW OF CURRENT
NATIONAL MEDICAL DEVICE REGULATORY SYSTEMS - TRENDS
low
hig
h
highlow
Ha
rmo
niz
ati
on
(G
HT
F /
MD
PW
G)
Comprehensiveness
SingaporeEU, EFTA
CanadaArab Saudi
Chinese Taipei
Japan
USAKorea
Thailand
ChinaBrazil
ColumbiaArgentina
Pakistan
New Zealand
Bangladesh
India South AfricaNOTES:
• Position in clusters not necessarily
significant
• Subjective assessment of many variables
• Variables not weighted
• Not all countries that regulate medical
devices shown
• Some countries moving faster than others
and with different paths
Brunei
Cambodia
LaosVietnam
Indonesia
Myanmar
Malaysia
Reference: M. Gropp; Institute of Medicine, Washington, D.C; 2-3 March 2011
Background
�Policy direction: Cabinet decision 2005
�Policy: Regulatory framework for the control of medical devices in Malaysia– Based on & harmonized with global regulatory
model
– Using the WHO model, in-line with WTO agreement
– Adoption of ASEAN AMDD and
– Adoption of major trading partners eg USA, Japan, Canada, EU and Australia regulatory requirements
Aims of the Regulatory Framework
� Conducive environment
for medical devices
manufacturing
� Facilitate trade and export
� Promote health tourism
Ensure public health
and safety Facilitate trade and
industry� Assurance for safety and
performance
� Timely access for beneficial medical technologies
� Prevent dumping ground for unsafe and defective medical devices
� Third party service for maintenance
Harmonised Regulatory Framework
• Definition of Medical Device
• Classification of Medical Device
• Pre-Market Requirements such as Essential Principles of Safety and Performance (6 Principles and 11 Performance)
• Requirements for placement on market such as labelling & advertisement
• Post Market requirements such Vigilance and Surveillance
Medical Device
•Diagnostic
•Therapeutic
Implantable
Medical Device
Active Others
(Non-Active)
Non-Invasive Invasive
Class A Class B Class C Class D
Engineering Services Division Ministry of Health
Medical DevicesMedical Devices
Chief Executive, officers, servants
MEDICAL DEVICE AUTHORITY
MINISTER OF HEALTH
MEDICAL DEVICE AUTHORITY
http://www.mdb.gov.myucture of Medical Device
Regulatory System
MEDICAL DEVICE REGULATORY SYSTEM
MEDICAL DEVICE AUTHORITY ACT 2012
(ACT 738)
MEDICAL DEVICE ACT 2012 (ACT 737)
CABs
Establishments•Manufacturers•LARs•Distributors•Exporters
Users
.. gives powers to
…
.. gives powers to
…
USAGE & MAINTENANCE
• Users shall use, maintain &
dispose off medical devices
appropriately
• Users shall apply for permit to
use/operate designated medical
devices
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
MDA will allow:-
• registered medical
devices to be
placed into the
market
• licensed establishments
to do their
business
ONLY THEN
MEDICAL
DEVICES WILL
BE MADE
AVAILABLE ON
THE MARKET
MDA will allow:-
• registered medical
devices to be
placed into the
market
• licensed establishments
to do their
business
ONLY THEN
MEDICAL
DEVICES WILL
BE MADE
AVAILABLE ON
THE MARKET
Overview of The Regulatory System
PRE-MARKET REVIEW
All Manufacturers of medical
devices shall -
• ensure their products
conform to EPSP
• ensure their products are
manufactured in accordance
with GMP
• collect evidence of
conformity
CAB verifies evidence of
conformity
PRE-MARKET PLACEMENT ON-MARKET POST-MARKET
MEDICAL DEVICES ARE
REGISTERED
• All Manufacturers (or LARs) apply for register
medical devices
MANUFACTURERS AND
DISTRIBUTORS APPLY
FOR LICENCE
• ensure compliance to GDP & advertising
requirements- Distributor
• apply for establishment license to distribute
medical devices
MDA monitors compliance to requirements & takes appropriate
actions in accordance with the provisions of the law
Premarket
Definition
Device
Manufacturer
Labelling
Brief Info
Instruction for
Use
Standards
Indigenous
International
Essential
Principles
Essential
Principles
6 General
Principles
11 Design and
Manufacturing
Conformity
Assessment
Declaration of
Conformity
QMS / GDPMD
CSDT
Technical Documentation
Classification
4 risk classes
Risk Criteria
Regulator
Documentation Review
Register Medical
Device
Post market Surveillance
Procedure
Establishment
Intended Use
Indication
Contra-IndicationEstablishment DetailsRegulation Info. Details
Premarket
Definition
Device
ManufacturerLabelling
Brief Info
Instruction
for Use
Standards
Indigenous
International
Essential Principles
6 General
11 Design and
Manufacturing
Conformity
Assessment
Declaration of
Conformity
QMS / GDPMD
CSDT
Technical
Documentation
Classification
4 risk
classes
Risk
Criteria
Regulator
Documentation
review
Register Medical Device
Post market
Surveillance
Procedure
Establishment
Intended Use
Indication
Contra-IndicationEstablishment Details
Regulation Info
Details
Clinical Safety of Medical
Device
Clinical
Investigation
Data/Result
Evaluation:
Data
AppraisalSuitability
Contribution
of Results to
Safety
Performance
Criteria for
Appraisal
Clinical Evidence
Ethical CommitteeClinical Investigation
Design
Quality
Records
Clinical
Experience
Report
Literature
search
Considering the need for a
clinical investigation
Testimonial from
users
Systematic
Review
Compliance of
Evidence
Risk Benefit
Qualitative
Data
Quantitative
Data
Pivotal Data
Premarket
Definition Labelling
Intended
Use
Instruction
for Use
Standards
Essential
Principles
Conformity
Assessment
Declaration of
Conformity
QMS / GDPMD
CSDT
Technical
Documentation
Classification Regulator
Documentation
Approve
Registration
Post market
Surveillance
Procedure
Clinical Safety of
Medical Device
Clinical Investigation
Data/Result
Evaluation:
Data
AppraisalSuitability
Contribution of
Results to
Safety
Performance
Criteria for
Appraisal
Systematic Review
Compliance of
Evidence
Risk Benefit
Clinical Evidence
Ethical CommitteeClinical Investigation Design
Device
Manufacturer
Indigenous
International
6 General
11 Design and
Manufacturing
4 risk
classes
Risk
Criteria
Quality
Management
System (QMS)
Supplier/
Product
Controls
Auditing Auditing in SG4
Risk
Management
Management
Responsibilities
Documentation and Communication
Process
ValidationInstallation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Delivery,
Measurement and
Monitoring
Feedback and Communication
Statistical Method and Tools
Processes that should be validated
Conduct of a validation
Use of Historical Data
Quality Records
Clinical Experience
Outsourcing
Planning
Design and Development
Traceability
Purchasing Controls and Acceptance Activities
Production and Process Controls
Servicing
Analysis of Data
Corrective and Preventive Action
(CAPA)
Maintaining a state of
validation
Planning
Selection of
potential supplier
Supplier Evaluation
and Acceptance
Finalization of controls
and responsibilities
Report
Literature search
Considering the need for a
clinical investigation
Testimonial from
users
Safety via
clinical
evidence
Safety via
QMS
Qualitative Data
Quantitative Data
Pivotal Data
MEDICAL DEVICE REGULATION APPLICATION
MANUFACTURER
Device
Requirements/Intended
Use
Design
Input/Specifications
Design
Design Verification
Pilot Production
Device Validation
Manufacturing
Placing On The Market
Market Performance
Obsolescence/disposal
Definitions
The Essential
Principles/Standards
QMS Design Control/ Risk
Analysis
QMS Design Control/ Risk
Assessment
QMS GMPQMS GMP
Product Lifecycle
Start
Product Lifecycle
End
QMS Design Control/ Risk
Assessment
Process ValidationProcess Validation
Clinical Evidence
QMS GMP
Labelling/Advertisement
QM
S a
nd
Ris
k M
an
ag
em
en
t a
re a
pp
lica
ble
th
rou
gh
ou
t th
e c
om
ple
te p
rod
uct
life
cycl
e
Te
chn
ica
l In
form
ati
on
Device Classification
CS
DT
Conformity Assessment
Registration of Medical Device
Approval Registration
Usage, Maintenance
and Servicing
Post Market Surveillance
and Vigilance
Au
dit
s –
Inte
rna
l a
nd
Ext
ern
al
Ce
rtif
ica
tio
n
Co
ve
rag
e o
f th
e c
om
ple
te q
ua
lity
ma
na
ge
me
nt
syst
em
• Design & development
• Manufacture, import/
export
• Packaging, labeling,
storage
POST-MARKETPRE-MARKET PLACEMENT
ON MARKET
• Distribution
• Supply
• Advertising
• Surveillance & vigilance
• Installation, T&C,
maintenance, calibration,
repairs
• Operation, usage
• Decontamination,
decommission, disposal
Why the WHO Model?
Medical Device Lifecycle – What are
the Activities?
Elements of Regulatory Program
USEUsage, personnel,
maintenance
DEVICESafety, quality and
Performance according to EPSP
ACTIVITIESPre-market, placement on the
market, post-market
AUTHORITY TO GOVERN THE ELEMENTS
MEDICAL DEVICES LIFE CYCLE IN MEDICAL DEVICES LIFE CYCLE IN MEDICAL DEVICES LIFE CYCLE IN MEDICAL DEVICES LIFE CYCLE IN
HEALTHCARE FACILITIES. Implications and HEALTHCARE FACILITIES. Implications and HEALTHCARE FACILITIES. Implications and HEALTHCARE FACILITIES. Implications and
roles of regulation roles of regulation roles of regulation roles of regulation
Procurement
Usage
Disposal
Hosp. DevicesHosp. Devices
register
Incident
reporting
Assessment HTA
Device
Assessment-HTA
Training
Replacement Planning,
User
requirements
Field Safety
Corrective
Actions
Installation/Testing &
Commissioning/Acceptance
MDA
Devices register
Establishment
License
Maintenance
MDA Devices
registry
Compentency of
Biomedical Engrs
Compentency of
Biomedical Engrs
Hosp. ensure
Devices are regtrd
Est. icenced
Hosp. ensure
Devices are regtrd
Est. licenced
Hosp. Hosp. ensure
T&C done
Technology
pressureFast changing (online)
HarmonisationStandards/regulations
Customer’s
expectationFast, quality ,cost
Training and
capacity buildingCompetency, knowledge
AwarenessDialog, Campaign
Regulatory70,000 device, impact
EnforcementLegal capability
StandardsMandatory, voluntary,
industry
Inter Agency
CooperationMDPWG, AHWP GHTF
GlobalisationWTO, Bilateral
The Medical
Device Authority
Challenges to the Authority
Medical Device
Regulatory Control
Program
Training for Regulators Premarket Requirements
Placement on Market
Post Market Requirements
Act 738
Fees and BudgetaryAct/Regulation/
Guidance
Notes/QMS
Harmonisation
National/International
Affairs and Policy
Computerization (ICT)
Resource Centre
Capacity
BuildingACT 737
Awareness program
for
Consumer/End
User/Manufacturer/
Trader/Distributor/
Policy
Marker/researcher/ etc
Infrastructure
Legal
Framework
Medical
Device
Authority
MRA/Agreements
Enforcement
International
Forums
Human Resource
Finance
Legal Support
Thank You