medical device authority - ministry of health malaysia - downloads
TRANSCRIPT
TRANSITION PLAN FOR
THE IMPLEMENTATION
OF MEDICAL DEVICE
ACT 2012 (ACT 737)
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
Seminar on
MEDICAL DEVICE ACT 2012 (ACT 737)PICC, Putrajaya
28 June 2012
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
MDA monitors compliance to requirements & takes appropriate
actions in accordance with the provisions of the law
PRE-MARKETPLACEMENT ON-
MARKETPOST-MARKET
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
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
CAB verifies evidence of
conformity
OVERVIEW OF THE REGULATORY
FRAMEWORK
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
• 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
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-Moderate
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
C High-Moderate
Lung ventilator, orthopedic implants, baby incubator, blood 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
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)
A
B
C
DR I S K
Device risk/class
Reg
ula
tory
co
ntr
ol
RISK-BASED CLASSIFICATION &
REGULATORY CONTROL
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
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
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
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
Essential Principles of Safety & Performance of Medical Device
CONFORMITY ASSESSMENT
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
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)
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
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
CONFORMITY ASSESSMENT
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
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
CA PROCESS & PARTIES INVOLVED
Manufacturerconducts CA on;(i) QMS & PMS(ii) Product safety & performance (summary tech doc & DoC
CONFORMITY ASSESSMENT
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
CONFORMITY ASSESSMENT
Class QMS PMS systemTech doc
CSDTDoC
Registration
& licensing
Class A,
Class A(S)
Class A(M)
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
Prepare, make
available upon
request. For
Class B may
be reviewed for
conformity to
EPSP
Prepare,
sign &
submit
for
review
Perform
according to
requirementsClass B
Class C Establish, maintain
full QMS make
available for audit
Prepare &
submit for
reviewClass D
Level of CA A –
Se
lf
decla
re
B
C
D –
Pro
du
ct design
&
man
ufactu
ring co
ntro
l
R I S K
The level of CA is proportional to the
risk associated with the device
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
r
MEDICAL DEVICE REGISTRATION ROUTES
A
Medical
device?
Class?
Class A Sterile MD
-ISO 13485 (In-House)
-ISO 13485 (Sterile Services)
-Process Validation (Report)
Class A Measuring Function MD
-Process Validation (Report)
Decision
B, C, D
Pay fee
MEDICAL
DEVICE
REGISTER
Grouping:
• Single
• System
• Kits
• Group
1.Application Form
2. DC from Product Owner/Manufacturer
3.CSDT
4. Class B, C if Required- Clinical evidence
Class C&D – Clinical Evaluation
Yes
Yes
No
Stop
Stop
No
Qualified
for
abridged?
No
Conformity Assessment By CAB or MDA
1. Technical File
2. ISO 13485 QMS
Yes
Evaluation
B, C, D
OK?
Class A
1.Application Form
2. Declaration of conformity
3. Certified QMS. If no, attestation by manufacturer
4. Simplified CSDT
Yes
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
LICENSING OF ESTABLISHMENTS
Imported device
Importer
Authorized
representative
Foreign
manufacturer
Distributor
Local
manufacturer
Distributor
Relationship between different
establishments
Locally-made device
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
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
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
LICENSING OF ESTABLISHMENTS
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
LICENSING OF ESTABLISHMENTS
Requirements Local
manufacturer
Authorized
repImporter Distributor
• 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
GDPMD FOR AUTHORIZED REP,
IMPORTER & DISTRIBUTOR
Imported medical devicesDistributor
Importer
Local
authorized
representative
Foreign
manufacturer
Distributor
Importer
Local
manufacturer
Distributor
Locally-made medical devices
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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..
– To be submitted to AG’s Chamber: August 2012
• Forms
• Fee structure
• Criteria
• Conditions
• Procedures
• Other details
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
CURRENT STATUS: GUIDANCE
DOCUMENTS
Awaiting publication Under development
(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
(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
(i) Conformity assessment
body
(ii) Declaration of
Conformity
(iii) Guidelines for product
registration
(iv)Grouping of medical
devices
Guidance Documents
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
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
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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
Preparation & development of
MD Act
Preparation & development of
computerized system
Preparation & development of
subsidiary legislations
Appointment of members of
MD Authority
Appointment of Chief
Executive of MD Authority
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
Passing
of MD &
MD
Authority
Bills
3-Oct-2011
Gazette-
ment of
MD &
MD
Authority
Bills
30-Dec-2011
Announcement
of appointed
dates of
implementation
MD & MD
Authority Acts
End Feb2 012
Establish-
ment of
MD
Authority
31-July-2012
Appointed
date of
implement-
ation of MD
Act
31-Oct-2012
Mandatory
implementation
MD Act
31-Oct-2014
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2011 2012 2013 2014 2015
Voluntary Transition Mandatory
Gazettement of Bills
Passing of Bills
Establishment of MD
Authority
Appointed dates of
implementation MD Act
Mandatory implementation
of MD Act
NOW TO MANDATORY PHASE
Reg
istr
ati
on
of
Pro
du
cts
an
d C
AB
s
Phase 1: Registration of Class A
Phase 2: Registration of CAB
Phase 3: Registration of Class D
Phase 4: Registration of Class B &C
Phase 5: Registration of IVD
Lic
en
sin
g o
f
Es
tab
lis
hm
en
ts
Phase 3: Imposition of other obligations
Phase 2: Imposition of GDP for other establishments
Phase 1: Imposition of ISO13485 for manufacturers
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
June July August September October
NOW TO MANDATORY PHASE
Development
of GD
Development of CAB registration system
Implementation of
CAB registration
Finalization of GD
Comments of GD from
interested parties
CAB Registration System
CA
B g
uid
an
ce
do
cu
me
nt (G
D)
CA
B r
eg
istr
ation
syste
m
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA
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