Medical Device Authority - Ministry of Health Malaysia

TRANSITION PLAN FOR
THE IMPLEMENTATION
OF MEDICAL DEVICE
ACT 2012 (ACT 737)
Seminar on
MEDICAL DEVICE ACT 2012 (ACT 737)
PICC, Putrajaya
28 June 2012
MEDICAL DEVICE CONTROL DIVISION, Ministry of Health Malaysia ●
Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya●
www.mdb.gov.my ● [email protected] ● Tel: 603-88850600 ● Fax: 603-88850759
OVERVIEW OF 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 monitors compliance to requirements & takes appropriate
actions in accordance with the provisions of the law
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
RISK-BASED CLASSIFICATION &
REGULATORY CONTROL
• 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 (non-invasive or
invasive with respect to body orifices,
surgically invasive interventions,
central circulatory system, central
nervous system)
R
I
S
K
Device risk/class
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
CONFORMITY ASSESSMENT
Conformity assessment (CA):
Systematic examination of evidence
generated and procedures
undertaken by the manufacturer
under the requirements established
by the Regulatory 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
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
What To Look For In CA?
Objective evidence for
conformance to Essential
Principles of Safety &
Performance of Medical
Device –
 6 general principles
 11 design and manufacturing
principles
CONFORMITY ASSESSMENT
Essential Principles of Safety & Performance of Medical Device
General Principles
Medical device should be designed &
manufactured in such a way that:
 no compromise to clinical condition or safety of
patients, or safety and health of users or other
persons
 control the risk so that residual risk is brought
down to an acceptable level
 suitable for one or more of the functions
within the scope of the definition of a medical
device
 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
 characteristics and performances during their
intended use will not be adversely affected
under transport and storage conditions
 benefits must be determined to outweigh any
undesirable side effects
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Design and Manufacturing Principles
 Chemical, physical and biological properties
 Infection and microbial contamination
 Manufacturing and environmental properties
 Devices with a diagnostic or measuring
function
 Protection against radiation
 Requirements for medical devices connected
to or equipped with an energy source
 Protection against mechanical risks
 Protection against the risks posed to the
patient by supplied energy or substances
 Protection against the risks posed to the
patient for devices for self-testing or self administration
 Information supplied by manufacturer
 Performance evaluation including where
appropriate, clinical evaluation
CONFORMITY ASSESSMENT
Elements of CA
 QMS (ISO 13485 or equivalent, GDPMD)
 Post-market surveillance system (GHTF
recommendations)
 Summary technical documentation (ASEAN CSDT)
 Declaration of conformity (DoC) (GHTF
recommendations)
 Registration of medical device & licensing of
establishment
Declaration of Conformity
(DoC)
• A DoC is a declaration made
by the manufacturer of a device
that the device is in conformity
with the regulatory
requirements
• DoC declares that the
manufacturer guarantees that
each piece of the device sold is
in conformity with the
regulatory requirements
Summary Technical Documentation
• Format – ASEAN CSDT
• Compliance to EPSP (GHTF
recommendations - Essential Principles of
Safety & Performance of Medical Devices)
• Acceptable standards or equivalence will
be widely used (GHTF recommendations Role of Standards in the Assessment of
Medical Devices)
• CAB determines the adequacy of the
documented evidence to support
attestation of conformity
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Quality Mgmt System (QMS)
• For manufacturer, ISO 13845 or
equivalent
–Class A & B products, can exclude
design control, process control,
inspection & testing
–For Class C, full QMS
–For Class D, full QMS
• PMS system
• Technical evaluation of sterilization
process (if any)
• For LAR, importer, distributor:
GDPMD
Post-Market Surveillance
System (PMS)
• Distribution records
• Complaint records
• Adverse incident reporting (GHTF
recommendations - Medical Devices
Post Market Surveillance: Global
Guidance for Adverse Event
Reporting for Medical Devices)
• FSCA reporting (GHTF
recommendations - Medical Devices
Post Market Surveillance: Content of
Field Safety Notices)
CONFORMITY ASSESSMENT
CA PROCESS & PARTIES INVOLVED
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
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Manufacturer
conducts CA on;
(i) QMS & PMS
(ii) Product safety
& performance
(summary tech doc
& DoC
CAB reviews
evidence of
conformity
Authority reviews
& registers product
& licenses
establishment
What is a CAB?
 A body authorized by the Authority to perform
specified CA activities to determine whether the
relevant requirements in technical regulations or
standards are fulfilled
 CAB is independent of the organization that provides
the product and is not a user of the product (3rd party)
 Authority will monitor the performance of the CAB
and, if necessary, withdraw authorization
C
Level of CA
R
Class
Class A,
Class A(S)
Class A(M)
Class B
Class C
Class D
QMS
PMS system
Est & maintain –
can excl design &
dev control. Class A
may be audited for
special cases. For
Class B, make
available for audit
Establish &
maintain adverse
event reporting
procedure for
audit. For Class
A, audit may be
required to
investigate
specific safety or
regulatory
concerns
Establish, maintain
full QMS make
available for audit
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
B
A – Self
declare
The level of CA is proportional to the
risk associated with the device
I
Tech doc
CSDT
Prepare, make
available upon
request. For
Class B may
be reviewed for
conformity to
EPSP
Prepare &
submit for
review
D – Product design &
manufacturing control
CONFORMITY ASSESSMENT
S
K
DoC
Registration
& licensing
Prepare,
sign &
submit
for
review
Perform
according to
requirements
WHAT DO WE NEED TO IMPLEMENT THE
REGULATORY SYSTEM?
•
•
•
•
Legal support, ie the Acts
Subsidiary legislations & guidance documents
Medical Device Authority & organization
Registration & licensing system
–
–
–
–
–
Internal processes & procedures
Register, database & resource center
Forms
Criteria
Procedures
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
MEDICAL DEVICE REGISTRATION ROUTES
B, C, D
Stop
Conformity Assessment By CAB or MDA
1.
2.
No
Technical File
ISO 13485 QMS
Stop
No
Medical
device?
No
OK?
Qualified
for
abridged?
Yes
Evaluation
Decision
Yes
Yes
Grouping:
• Single
• System
• Kits
• Group
Yes
B, C, D
Class?
A
r
1.Application Form
2. DC from Product Owner/Manufacturer
3.CSDT
4. Class B, C if Required- Clinical evidence
Class C&D – Clinical Evaluation
Class A Sterile MD
-ISO 13485 (In-House)
-ISO 13485 (Sterile Services)
-Process Validation (Report)
Class A Measuring Function MD
-Process Validation (Report)
Class A
1.Application Form
2. Declaration of conformity
3. Certified QMS. If no, attestation by manufacturer
Division
4. Simplified CSDT
Medical Device Control
MINISTRY OF HEALTH MALAYSIA
Pay fee
MEDICAL
DEVICE
REGISTER
LICENSING OF ESTABLISHMENTS
 Establishment means a
person/organization who is
either a manufacturer,
authorized representative (for
foreign manufacturer), importer
or distributor of medical
devices, but does not include a
retailer
 Different type of establishment
has different roles &
responsibilities – different set
of control
 Establishment must possess
valid license to carry out
activities related to medical
devices in Malaysia
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Foreign
manufacturer
Importer
Authorized
representative
Local
manufacturer
Distributor
Distributor
Imported device
Locally-made device
Relationship between different
establishments
LICENSING OF ESTABLISHMENTS
Authorization: Appropriate
authorization from the
respective establishment is
required as a pre-requisite for
the issuance of license
 Authorized rep must be
authorized by foreign
manufacturer
 Importer must be authorized
by authorized rep to import
devices on its behalf
 Distributor must be
authorized by manufacturer/
authorized rep to distribute
devices on its behalf
 An entity may apply for
license for different types of
establishment
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Manufacturer as defined in Section 2 of MD Bill 2011:
definition of “manufacturer”
Authorized representative as defined in Section 2 of
MD Bill 2011: definition of “manufacturer”
• Authorized representative must be natural or legal
person with business registration in Malaysia.
• It must maintain linkage with its foreign
manufacturer and should be able to obtain the
support of its foreign manufacturer whenever
required.
Distributor: Any natural or legal person in the supply
chain authorized by the manufacturer/authorized
representative to further the availability of medical
devices to the end-user. In some circumstances,
more than one distributor may be involved in this
process
Importer: Any natural or legal person authorized by
authorized representative, who first makes a
medical device manufactured in other countries,
available in the Malaysian market
LICENSING OF ESTABLISHMENTS
Requirements
• Establishment details
• Appropriate authorization
• Procedures for;
– Distribution records
– Complaint handling
– Adverse incident reporting
– Field safety corrective
action
• List of medical devices
• ISO 13485 or equivalent
• Good Distribution Practice for
Medical Devices (GDPMD)
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Local
manufacturer
Authorized
rep
Importer
Distributor
GDPMD FOR AUTHORIZED REP,
IMPORTER & DISTRIBUTOR
Foreign
manufacturer
Local
manufacturer
Local
authorized
representative
Importer
Distributor
Distributor
Imported medical devices
Importer
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Locally-made medical
devices
Distributor
SAVINGS & TRANSITIONAL
Section 80 of MD Act 2012 (Act 737): Savings and
transition
– All medical devices shall be registered within 24
months from the appointed date
– All establishments shall be licensed within 12 months
from the appointed date
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
CURRENT STATUS: THE ACT
• MD Act 2012 (Act 737) & MD Authority 2012
(Act 738)
– 3 Oct 2011: Passed by Lower House of Parliament
– 7 Dec 2011: Passed by Upper House of Parliament
– Already gazetted
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
CURRENT STATUS: ORGANIZATION
• New statutory body setup: Medical Device Authority
– early Q3 2012
• Human resource – already approved PSD
MEDICAL DEVICE
AUTHORITY (MDA)
A body corporate with the following
members
- DG of Health as the Chairman
- Chief Executive of the MDA
- a representative of Min of Finance
- a representative of Min of Health
- not more than five persons
appointed by the Minister, who have
expertise and experience in medical
device matters
Functions of MDA
• To implement, enforce, consider and recommend reform
to the medical device laws
• To perform the following
- to regulate all matters
- to provide consultancy & advisory service and any
other services
in relation to medical device, its industries and activities
• To utilize property of the Authority in such manner as the
Authority may think expedient
• To impose fees or charges for services rendered
Committees appointed by MDA
- to assist in the performance of the functions of the Authority
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
CURRENT STATUS: SUBSIDIARY
LEGISLATIONS
• MD (Pre-Market) Regulations
– 1st phase: draft pre-market regulations is ready
• Registration of MD
–
–
–
–
–
–
–
–
Classification
Grouping
Conformity assessment procedure
Application procedure for registration
Renewal of registration
Changes concerning registered MD
Exemption
Cancellation of registration
• Registration CAB
• Establishment license
• Etc..
•
•
•
•
•
•
Forms
Fee structure
Criteria
Conditions
Procedures
Other details
– To be submitted to AG’s Chamber: August 2012
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
CURRENT STATUS: GUIDANCE
DOCUMENTS
Guidance Documents
Awaiting publication
(i) Definition of Medical
Device
(ii) Risk Based
Classification
(iii) Essential Principles of
Safety & Performance
of Medical Device
(iv) Common Submission
Dossier Template
(v) Good Distribution
Practice for Medical
Devices
Under development
(vi) IVD Medical Device
Classification System
(vii) Essential Principles
of Safety and
Performance for IVD
Medical Devices
(viii) Conformity
Assessment for IVD
Medical Devices
(ix) Common Submission
Dossier Template for
IVD Medical Device
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
(i) Conformity assessment
body
(ii) Declaration of
Conformity
(iii) Guidelines for product
registration
(iv) Grouping of medical
devices
REGISTRATION OF MEDICAL DEVICES
 Medical device regulatory system
is based on safety & performance
of medical devices throughout
their life cycle
 Prior to registration of a medical
device, CA is conducted to
provide objective evidence of
safety & performance a medical
device
 Only registered medical devices
can be placed into the market
 Establishments dealing with
medical devices must comply
with conditions and carry out
their obligations
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
 Who shall be responsible?
– Licensed local manufacturers or
authorized rep
 What would be required?
– Submission of CSDT
– Submission of DoC
– Establishment, maintenance and making
available of QMS & PMS documents for
audit
 Upon approval, the medical device will be
put in the Medical Device Register
Abridged Assessment
• Applicable for medical devices which have
already approved by the relevant authority
to be marketed in US, EU, Canada,
Australia, Japan.
• Otherwise, full assessment shall be done
CURRENT STATUS: MEDC@ST
• New registration & licensing system
ESTABLISHMENT LICENSING
MEDICAL DEVICE REGISTRATION
CAB REGISTRATION
COMPETENCY REGISTRATION
SERVICE PROVIDER REGISTRATION
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
MEDC@ST: ESTABLISHMENT LICENSING
Authorized representative
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
MEDC@ST: MEDICAL DEVICE
REGISTRATION
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
MEDC@ST: MEDICAL DEVICE
REGISTRATION
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
NOW TO MANDATORY PHASE
Passing
of MD &
MD
Authority
Bills
Gazettement of
MD &
MD
Authority
Bills
Announcement
of appointed
dates of
implementation
MD & MD
Authority Acts
Establishment of
MD
Authority
Appointed
date of
implementation of MD
Act
Mandatory
implementation
MD Act
3-Oct-2011
30-Dec-2011
End Feb2 012
31-July-2012
31-Oct-2012
31-Oct-2014
Preparation & development of
MD Act
Appointment of members of
MD Authority
Preparation & development of
computerized system
Appointment of Chief
Executive of MD Authority
Preparation & development of
subsidiary legislations
Transition of MD Control Div to assist in
the establishment of MD Authority
Preparation & development of regulations, guidance documents & standards for the implementation of MD Act
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Licensing of
Establishments
NOW TO MANDATORY PHASE
Mandatory implementation
of MD Act
Establishment of MD
Authority
Gazettement of Bills
Passing of Bills
Q1
Q2
Q3
Phase 2: Imposition of GDP for other establishments
Phase 1: Imposition of ISO13485 for manufacturers
Phase 5: Registration of IVD
Registration of
Products and CABs
Appointed dates of
implementation MD Act
Phase 3: Imposition of other obligations
Q4
Q1
2011
Q2
Phase 4: Registration of Class B &C
Phase 3: Registration of Class D
Phase 2: Registration of CAB
Phase 1: Registration of Class A
Q3
2012
Voluntary
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Q4
Q1
Q2
Q3
Q4
Q1
2013
Q2
Q3
2014
Transition
Q4
Q1
Q2
Q3
2015
Mandatory
Q4
NOW TO MANDATORY PHASE
CAB guidance
document (GD)
CAB registration
system
CAB Registration System
Implementation of
CAB registration
Development of CAB registration system
Finalization of GD
Comments of GD from
interested parties
Development
of GD
June
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
July
August
September
October
SUMMARY
• Regulatory framework & legal support are in
place
• Current status: Work is progressing – putting
the detailed pieces together
• Moving forward – regulatory activities will be
introduced in phases, timeline
• Awareness & consultations
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
….Thank you for your
attention
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA