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Conditions for ensuring the safety

and performance of medical devices

Vendor Manufacturer

SHARED RESPONSIBILITIES
COMMUNICATION
PARTICIPATION
EDUCATION

Government

User

Public/Patient Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Overview of
Medical Devices
Regulatory Framework

Medical Device Regulatory System and Its


Impact on Healthcare Facilities
Hospital Ipoh
24 April 2008

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Overview of
Medical Devices
Regulatory Framework

• Introduction • Critical Elements of


• Aims of Medical Regulation
Device Regulation • Scope of Regulation
• Definition of Medical • Conformity
Device Assessment and
• Medical Device Registration &
Licensing
Classification Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Public health &
safety issues
• Unavailability of pre-market control to assess safety, effectiveness
and quality of medical devices that may have resulted in the
dumping ground for sub-standard, unsafe and ineffective devices.
• Inadequate information for the public and health professionals to
make informed choices on medical devices: deprives patients from
getting appropriate treatment and may even result in patient or
user injury.
• Lack of control over the usage of various medical devices, the
usage of various medical devices without appropriate training by
non-medical professionals and the usage of medical devices that
have not been properly maintained and calibrated.
• The absence of post-market reporting system to identify and
monitor medical devices with problems in theMedical
market.
Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Introduction
• 16 Feb 2005: Cabinet approved the
proposal to develop Medical Device
Regulatory Program
• Aug 2005: Medical Devices Bureau
was established
• Functions of MDB
– Policy planning
– Registration/licensing
– Surveillance and vigilance
– International affairs and industrial assistance
– Administration & management
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Introduction:
Organization Chart
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA

POLICY REGISTRATION SURVEILLANCE INT’L AFFAIRS & ADMINISTRATION


PLANNING & LICENSING & VIGILANCE IND ASSISTANCE & MANAGEMENT
 To plan and establish  To plan and determine  To plan and implement  To provide consultation/  General management
policies and strategies registration/licensing post-market advice on MD  Finance, supply and
for the implementation requirements & surveillance & vigilance regulation to the contract
of MD regulatory procedures activities such as affected industry and  Personnel
program  To receive, process and product alert and recall stakeholders  Logistic
 To develop suitable assess application for  To monitor compliance  To act as a reference
activities for the registration/ licensing of  To conduct audit, centre for product
implementation of MD establishments & MD inspection and listing, terminology and
regulatory program  To approve, reject, investigation focal point in matters
 To plan for the required suspend registration/ related to MD
infrastructures, incl licenses regulation
computerization  To take part in
 To prepare and draft international affairs
legislative documents, such as MRA and
standards, guidance Medical Devices Bureau
bilateral/multilateral
documents negotiationsMINISTRY OF HEALTH MALAYSIA
Introduction:
Organization Chart
 To plan and establish policies and strategies
for the implementation of MD regulatory
program
 To develop suitable activities for the
implementation of MD regulatory program
 To plan for the required infrastructures, incl
computerization
 To prepare and draft legislative documents,
standards, guidance documents
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Aims of
Regulation
• Ensure public health & safety
– Provide assurance for quality, safety,
performance
– Prevent defective & unsafe medical devices
– Timely access to beneficial medical devices
• Facilitate medical devices trade and
industry
– Rules-based environment for medical devices
industry
– Facilitate trade & export
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Definition of
Medical Device
What is a medical device?
The term “medical device”
covers any products used in
healthcare for the diagnosis,
prevention, monitoring or
treatment of illness or
handicap but excludes drugs
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Definition of
Medical Device
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 purpose (s) of;
• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
• investigation, replacement, modification, or support of the anatomy or of a physiological
process;
• supporting or sustaining life;
• control of conception;
• disinfection of medical devices;
• providing information for medical or diagnostic purposes by means of in vitro examination of
specimens derived from the human body; and
b) 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

GHTF/SG1-N29R16:2005 : Information Document Concerning the Definition of the Term "Medical Device“

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Definition of
Medical Device
 Medical devices encompass Global marketplace:
a wide array of products with
400,000 different medical
myriad uses
device products in some
 Medical devices range in 10,000 product categories
complexity from simple to
sophisticated system
 They cover a wide spectrum
of risk, whilst providing
benefit to patients

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Definition of
Medical Device
Categories and examples
Non-active implantable devices Stent, hip implant

Electromechanical devices Electrocardiograph

Single use (disposal) devices Bandage, dressing, syringe

Active implantable devices Cardiac pacemaker, neurostimulator

Hospital equipment (hardware) Patient bed, patient trolley

Dental devices Dentistry tools, drills, alloys & resins, dental floss

In-vitro diagnostics Devices for clinical chemistry, microbiology, genetic test

Ophthalmic & optical devices Contact lenses, optical lens, eye glasses, ophthalmoscope

Anesthetic/respiratory equipment Oxygen mask, anesthesia, breathing circuit, medical gas delivery unit

Technical aids for disabled Wheelchair, crutch, standing support, electrical bed

Diagnostic & therapeutic radiation X-ray machine, linear accelerator

www.gmdn.org/ Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Medical Device
Classification
A classification to categorize 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:
• Intended use
• Duration of use (transient, short-term and long-term)
• Part of human body (non-invasive or invasive with
respect to body orifices, surgically invasive
interventions, central circulatory system, central
nervous system) Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Medical Device
Classification
Class D

Class C
Device Class

Class B
Risk: Combination of the
Class A probability of occurrence of harm
and the severity of that harm

Device Risk
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Medical Device
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
B Low- Hypodermic needles, suction equipment, anesthetic breathing
Moderate circuits, aspirator, external bone growth simulators, hearing aids,
hydrogel dressings, patient controlled pain relief, phototherapy
unit, x-ray films
C High- Lung ventilator, orthopedic implants, baby incubator, blood
Moderate oxygenator, blood bag, contact lens disinfecting/cleaning products,
deep wound dressing, defibrillator, radiological therapy equipment,
ventilator
D High Pacemakers and their leads, implantable defibrillators, implantable
infusion pumps, heart valves, inter-uterine contraceptive devices,
neurological catheters, vascular prostheses, stents

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Critical elements of
Regulation

DEVICE
Pre-market review contributes
to device quality, safety
& performance

REPRESENTATION
Placement-on-market control
Measures ensure correct
product representation
USE
Post-market surveillance ensures
device in use continues to be
safe and effective

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Scope of Regulation: Medical Device
Life-Cycle
POST-
PRE- PLACEMENT
MARK
MARKET ON MARKET
ET
• Product safety & • Distribution, supply • Installation, T&C
p e r f o r m a n c e c h a i n • Maintenance, calibration
• Quality system • Advertising (product • Operation, usage
representation) • Decommission, disposal
• Surveillance & vigilance

Pre-market review Establishment Usage & maintenance


(review of submission, r e g i s t r a t i o n , control, post-market
testing, audit) MD registration, surveillance & vigilance,
appointment of CAB advertisement control audits, enforcement

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Registration and
Licensing
Functions
 To plan and determine registration/
licensing requirements & procedures
 To receive, process and assess
application for registration/ licensing
of establishments & MD
 To approve, reject, suspend
registration/licenses
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Pre & Placement on
Market
PRE- PLACEMENT
MARKET ON MARKET

• P r o d u c t s a f e t y & • Distribution, supply


p e r f o r m a n c e c h a i n
• Advertising (product
•Quality system
representation)
Pre-market review Establishment
(review of submission, r e g i s t r a t i o n ,
testing, audit), MD registration,
appointment of CAB advertisement control
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Conformity Assessment

Requirements
Systematic examination Procedures
established
of evidence generated undertaken by the
by the Regulatory
by the manufacturer manufacturer
Authority

to determine that a medical device is safe and performs as intended


by the manufacturer and, therefore, conforms to the Essential
Principles of Safety and Performance for Medical Devices

GHTF/SG1/N040: Principles of Conformity Assessment for Medical Devices


Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Conformity Assessment
“Conformity assessment is primarily the
responsibility of the medical device
manufacturer. However, it is done in the
context of the established regulatory
requirements and both the process and
conclusions are subject to further review by
the Regulatory Authority and/or Conformity
Assessment Body (CAB) in the countries
and regions where the device is sold ”
GHTF/SG1/N040: Principles of Conformity Assessment for Medical Devices
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Elements of
Conformity Assessment
submit
REGULATOR/CAB
Review submission
MANUFACTURER
NO YES
Conformity assessment of
quality management system:
• quality management system
• post-market surveillance system
REGISTRATION
Conformity assessment of
• Safe medical
MD safety and performance: devices
• summary of technical document
• Responsible
• declaration of conformity
establishments

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Conformity Assessment
Procedure (risk-based)
The level of regulatory
Conformity assessment

control (or conformity


assessment procedure)
procedure

applied to medical
devices is proportional to
the class of (or degree of
perceived risk associated
with) the device

Device Risk (Class)


Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Why
Conformity Assessment
1) Quality management system - Emphasises
that quality must be built during the design and
production of MD and be maintained throughout its
entire life cycle
2) Post-market surveillance system -
Ensures continued safety and performance of a
device after it is placed on the market
3) Summary Technical Documentation -
Provides summarised technical data of MD for
regulatory submission and pre-market review
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Why
Conformity Assessment
4) Declaration of Conformity - Provides legal
basis and assurance for making declaration that a
MD has been tested to an international standard
and has met regulatory requirements
5) Registration of manufacturers and MD -
Allows regulator to know “who” is selling “what” in
the market. This is especially important for
effective enforcement of local medical device
regulations and the exchange of post market
vigilance information

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Elements of
Conformity Assessment
submit
REGULATOR/CAB
Review submission
MANUFACTURER

Conformity assessment of NO YES


quality management system:
• quality management system
• post-market surveillance system
REGISTRATION
Conformity assessment of
• Safe medical
MD safety and performance: devices
• summary of technical document
• Responsible
• declaration of conformity
establishments

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Market
Clearance

submit
REGULATOR/CAB
Review submission
MANUFACTURER MARKET
NO YES
Conformity assessment of
quality management system:
• quality management system
• post-market surveillance system
REGISTRATION
Conformity assessment of
• Safe medical
MD safety and performance: devices
• summary of technical document
• Responsible
• declaration of conformity
establishments

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Please visit our website
www.mdb.gov.my

Thank You

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Licensing & Registration
• Registration of MD and establishments
dealing with MD is crucial in MD control
• Registration of MD manufacturers
demonstrates that their devices have
undergone the scrutiny and complied
with the essential requirements for safety
and performance
• Registry provides a list of establishments
& medical devices that have obtained
market clearance – useful for users and
regulator Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Licensing & Registration
• 2006: Administrative MeDVER (Voluntary
Registration Scheme for Establishments
Dealing with MD) with following aims:
– Confidence and image building process
– Familiarization
– Preparation for transition to mandatory phase
– Information network
• On-line registry of establishments
– Manufacturers
– Importers/exporters
– Distributors/vendors
– 550 establishments - > 40,000 MD
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Licensing & Registration

• Voluntary Registration for Medical


Devices Establishments
(MeDVER)

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
NEXT STEP
• MD registration (including control
of advertisement)
• CAB registration
• Table draft MD Bill in Parliament

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Quality Management System
• Good management of manufacturing
and production
– Poor management may bring about
inconsistency in the quality of the products
even when the original prototype has been
well designed
– To ensure product conforms to ERSP
– To ensure manufacturing processes are
properly managed
– Technical file, QMS, product testing
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Quality Management System
• Post-market surveillance system
– Assuring medical devices safety entails more
than the functioning of the device, it requires
oversight of the use of the devices at the post-
market stage
– Unfamiliarity with technology or operating
procedure, and the misuse of a device can
cause device failure even in the absence of
design or manufacturing defects
– Post-market surveillance study
– Adverse incident reporting
– Product recall
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Safety and Performance

Essential Requirements of Safety


& Performance of Medical Devices
– 6 general requirements
– 11 design and manufacturing
requirements
GHTF/SG1/N41R9:2005: Essential Principles of Safety and Performance of
Medical Devices

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
General Requirements
1) No compromise to clinical condition & safety of patients,
health & safety of users & other persons
2) Identify hazards, associated risks & foreseeable misuse;
eliminate/reduce risks; protection measures for risks that
cannot be eliminated; inform residual risks to users
3) Achieve the intended/specified performance and designed,
manufactured and packed in such a way that is suitable for
the functions
4) Characteristics and performances should not be adversely
affected by stresses during normal conditions of use and
proper maintenance
5) Characteristics and performances during the intended use
should not be adversely affected under transport and
storage conditions
6) The benefits outweigh any undesirable side effects
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Design and Manufacturing
Requirements
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 the manufacturer
11) Performance evaluation including, where appropriate, clinical
evaluation
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Declaration of Conformity

Evaluate all relevant clinical evidence to


establish safety and performance and any
undesirable side effects
Technical file collates information relating to safety
and performance

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
The use of Standards
• International standards
• National standards
• Industrial standards
• Vertical: products
• Horizontal: process, management
• Mandatory
• Voluntary

Helps in productivity, market competitiveness, export


capability
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
The use of Standards
Examples of adopted international standards
• ISO 13485:2003, Medical devices - Quality management systems -
Requirements for regulatory purposes
• ISO 14971:2000, Medical devices - Application of risk management to
medical devices; and its Amendment 1:2003
• MS 1961:2007 ISO/TR 14969:2004, Medical Devices - Quality
management systems – Guidance on the application of ISO 13485:2003
• MS IEC 61010-1:2006 Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 1: General requirements
Equipment - Dosimetric Instruments Used for Non-invasive Measurement
of X-ray Tube Voltage in Diagnostic Radiology
• ISO 10651-2:2004, Lung ventilators for medical use - Particular
requirements for basic safety and essential performance - Part 2: Home
care ventilators for ventilator-dependent patients
• MS 1927: Part 1:2006 EN 868-1 (1997), Packaging materials and systems
for medical devices which are to be sterilized - Part 1: General
requirements and test methods respiratory equipment

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Clinical Evidence
• Established equivalent
– Performance of closely similar devices already
on the market
– Published scientific literature
• Clinical investigation
– New technology
– New materials
– No information from similar device
– No scientific literature
– New population of patients
– New or additional intended use
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Clinical Investigation

Any designed and planned


systematic study in human
subjects undertaken to verify the
safety and/or performance of a
specific device

Medical Devices Bureau


MINISTRY OF HEALTH MALAYSIA
Labeling
• Labeling is very crucial in identifying a
medical device and specifying instructions
for its proper use
• Mislabeling of medical devices can result
in serious consequences for the user
• Label includes
– identification
– hazard warnings or cautions
– instructions for use
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA

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