medical devices authority (mda) - Medical Device Authority

MEDICAL DEVICES AUTHORITY (MDA)
MEDICAL DEVICES AUTHORITY, Ministry of Health Malaysia
Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya
http://www.mdb.gov.my ● [email protected]
Pihak Berkuasa Peranti Perubatan
KEMENTERIAN KESIHATAN MALAYSIA
CONTENTS
• Background
• Medical Device Industry
• Regulatory System
• Regulatory Framework
Pihak Berkuasa Peranti Perubatan
KEMENTERIAN KESIHATAN MALAYSIA
BACKGROUND: CABINET DECISION
• 16 Feb 2005:
Cabinet
approved the
proposal to
develop Medical
Device
Regulatory
Program in
Malaysia
 Development of MD Bill &
subsidiary legislations
 Establishment of an
organization to implement
MD Regulatory Program
 Development of MD
Registration & Surveillance/
Vigilance System
Pihak Berkuasa Peranti Perubatan
KEMENTERIAN KESIHATAN MALAYSIA
THE INDUSTRY IN MALAYSIA
• MDA has issued more than 2000 numbers of
establishments licenses
• About 18 000 applications for product
registration has been received to date, for
registration of more than 70 000 medical devices
STRUCTURE OF
REGULATORY SYSTEM
Pihak Berkuasa Peranti Perubatan
KEMENTERIAN KESIHATAN MALAYSIA
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
• Medical Device Regulation 2012
Prescribes requirements for registration, licensing and
conformity assessment of medical devices
Pihak Berkuasa Peranti Perubatan
MEDICAL DEVICES AUTHORITY MALAYSIA . http://www.mdb.gov.my
KEMENTERIAN KESIHATAN MALAYSIA
MEDICAL DEVICE AUTHORITY
http://www.mdb.gov.myucture of Medical Device
Regulatory System
MEDICAL DEVICE REGULATORY SYSTEM
MEDICAL DEVICE ACT
2012 (ACT 737)
.. gives powers to…
MINISTER OF HEALTH
MEDICAL DEVICE AUTHORITY
Chief Executive, officers, servants
.. gives powers to…
MEDICAL DEVICE
AUTHORITY ACT 2012
(ACT 738)
CABs
Users
Establishments
•Manufacturers
•LARs
•Distributors
•Exporters
TIMELINE
14 June 2012 : Establishment of
Medical Device Authority
MANDATORY
30 June 2013 : Effective date of
REGISTRATION
OF
Act 737
1 July 2013 : EffectiveDEVICES
date of
MEDICAL
MDR 2012
1 July 2013 - 1 July 2014 : Transitional
period for Licensing of Establishment
1I JulyJULY
2016
2013 - 1 July 2016 : Transitional Period
for Registration of Medical Devices
MEDICAL DEVICE AUTHORITY ACT 2012
(ACT 738)
Functions of MDA
• To implement, enforce, consider and recommend
reform to the medical device laws
• To perform the following
- to regulate all matters
- to encourage & promote the development
- to provide consultancy & advisory service and any
other services
in relation to medical device, its industries and
activities
• To impose fees or charges for services rendered
Pihak Berkuasa Peranti Perubatan
MEDICAL DEVICES AUTHORITY MALAYSIA . http://www.mdb.gov.my
KEMENTERIAN KESIHATAN MALAYSIA
MDA Structure
• Headed by Chief Executive
• 4 main divisions:
- Registration, Licensing & Enforcement
- Policy, Codes & Standards
- Technical Evaluation
- Finance and Administration
• Current work force: 60 permanent staff, 30
contract staff
10
CORE BUSINESS
Registration
Licensing &
Enforcement
•
•
•
•
•
•
Product Registration
Licensing of
Establishment
CAB Registration
Vigilance &
Surveillance
CFS/Import permit
Designated Devices
Policy, Codes &
Standards
•
•
•
•
•
Regulatory Auditing of
o QMS systems
o Post marketing
o Vigilance &
Surveillance
Policy
Industry Facilitation
Development of Codes
and Standards
GLP and new program
development
Technical
Evaluation
•
•
•
Scientific
Evaluation
Clinical
Investigation
ICT
DEFINITION OF MEDICAL DEVICE
Pihak Berkuasa Peranti Perubatan
KEMENTERIAN KESIHATAN MALAYSIA
Elements of Regulatory Program
DEVICE
Safety, quality and
Performance according to EPSP
ACTIVITIES
Pre-market, placement on the
market, post-market
USE
Usage, personnel,
maintenance
AUTHORITY TO GOVERN THE ELEMENTS
REGULATORY FRAMEWORK
Pihak Berkuasa Peranti Perubatan
KEMENTERIAN KESIHATAN MALAYSIA
MEDICAL DEVICES LIFE CYCLE IN
HEALTHCARE FACILITIES.
MDA
Devices register
Establishment
License
MDA Devices
registry
Replacement Planning,
User
requirements
Disposal
Hospitals ensure
Devices are registered &
Establishments licensed
Procurement
Maintenance
Device
Assessment-HTA
Installation/Testing &
Commissioning/Acceptance
Competency of
Biomedical Engrs
Hosp. ensure
T&C done
Usage
Field Safety
Corrective
Actions
Incident
reporting
Training
Hosp. Devices
register
Risk-Based Classification
• A classification of medical devices based on risk associated with the vulnerability of
the human body, the technical design and the manufacture of the medical device
 It uses a set of classification
rules based on:


Risk Level
Low
B
LowModerate
C
HighModerate
D
High
D
Class
A
C
B
A
Regulatory control

intended use
duration of use (transient,
short-term and long-term)
part of human body (noninvasive or invasive with respect
to body orifices, surgically
invasive interventions, central
circulatory system, central
nervous system)
R
I
S
Device risk/class
K
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,
anesthetic breathing circuits, aspirator,
external bone growth simulators, hearing
aids, hydrogel dressings, patient controlled
pain relief, phototherapy unit, x-ray films
Lung ventilator, orthopedic 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 catheters, vascular
prostheses, stents
The Regulatory Framework
PRE-MARKET
PRE-MARKET ASSESSMENT
Manufacturers of medical
devices shall • ensure their products
conform to EPSP
• establish appropriate quality
system for manufacturing
their products
• collect evidence of
conformity
CAB verifies evidence of
conformity
PLACEMENT ONMARKET
MEDICAL DEVICE
REGISTRATION
• Manufacturers (or LARs) apply
to register medical devices &
establishment license
ESTABLISHMENT LICENSING
Importers/distributors shall • ensure compliance to GDP &
advertising requirements
• apply for establishment license
to import/distribute medical
devices
POST-MARKET
SURVEILLANCE & VIGILANCE
Establishments shall • monitor safety & performance
of products
• carry out post-market
obligations, eg 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
MDA registers, issues licenses and monitors compliance to requirements &
takes appropriate actions in accordance with the provisions of the law
The responsibilities of manufacturer and
importer/distributor
Manufacturer:
• To ensure that medical devices manufactured to meet or
exceed the required standards of safety and performance
• To participate in post market surveillance (receiving and
reporting customer complaints/incidents)
Importer/Distributor:
• To ensure that medical devices enter the market or sold
comply with regulatory requirements
• To avoid making misleading or fraudulent claims or issuing
false compliance certificates
• To participate in post market surveillance (receiving and
reporting customer complaints/incidents)
The responsibility of the healthcare
institution/User
• To use the medical device only for the intended indications.
• To ensure the proper use of medical device by being a
competent user (having appropriate qualification, training and
experience).
• To share experience gained with medical devices with others
(user, distributor and manufacturer) by reporting any
incidents to a coordinating centre from which warnings can be
issued.
• To ensure proper maintenance of medical devices during
active use and safe disposal of unsafe/obsolete medical
devices.
The responsibility of the Authority
• To ensure that medical devices sold or made
available in the country and used in the healthcare
institutions are safe and effective throughout the
life span of the device by establishing and
implementing policies and regulations to control
medical devices
• To oversee the efforts of manufacturers/
importer/distributors and users in ensuring the
safety and performance of medical devices.
Please visit mdb.gov.my