Seguridad de dispositivos médicos y armonización mundial

28/09/2012
II Simposio Nacional de
la Calidad 2012
Seguridad de dispositivos
médicos y armonización mundial
25 de Setiembre 2012
Dr. Peter Lee
Consultor coreano
Director/Ingeniero jefe
KATS-KTL
Chief Engineer and Director of the International
Cooperation Center, KTL(Korea Testing Laboratory).
Engaged in diverse industrial fields such as a Medical
device control system, Certification, ISO management
system, CE marking, Inspection/Audit and Electric &
Electronic Products Safety/EMC test affairs from 1981
in the Republic of Korea.
Earned a Ph. Doctorate of Technology policy at Korea
Polytec University, Master of Industrial engineering
at Soongsil Univ. and B.E of Electronics engineering
at Chung-Ang Univ.
E-mail: kmlee1452@hanmail.net
1
28/09/2012
El milagro de
la República de Corea
A penas hace 50 años atrás.
Corea lo había perdido todo.
http://youtu.be/PpznfKHNDnw
“Haremos cualquier cosa” le suplicaron
los mineros al presidente de Alemania
Occidental.
El milagro de la República de Corea
K-Pop singers
PSY Gangnam Style + Idol Groups
http://youtu.be/9bZkp7q19f0
Horse-Riding Dance
Girls Generation
PSY - GANGNAM STYLE (강남스타일)
Singer Psy
Dong Bang Shin Gi
At NBC-TV “Today Show” in New York
Wonder Girls
2
28/09/2012
Topics
• Scope of Medical Device
- Definition, Classification, Basic Principle, Pre/Post
Market Safety, Areas of Improvements
• Overview and status of GHTF
- Harmonization, History, Purpose, Structure, Activities
• Introduction and Perspective of AHWP
- Overview, Objectives, Organization, Terms of Reference
What is a Medical Device?
• Defines a medical device as any
healthcare product that does not
achieve its principal intended
purposes by chemical action or
by being metabolized.
- As simple as a tongue depressor
or a thermometer
- As complex as robotic surgery devices
FDA's MDEpiNet - Improving Medical Device Safety and Effectiveness
3
28/09/2012
The Products US FDA regulate…
FDA Device Classification
• Medical Device Classes:
Class I
- General Controls
- Most exempt from premarket submission
Class II
- Special Controls
- Premarket Notification
Class III
- Premarket Approval
- Require Premarket Application
4
28/09/2012
GHTF MD Classification System
CLASS RISK LEVEL
A (I)
Low Risk
DEVICE EXAMPLES
Surgical retractors / tongue
depressors
B (IIa) Low-moderate Risk Hypodermic Needles / suction
equipment
C (IIb) Moderate-high Risk Lung ventilator / orthopedic
implants
D (III) High Risk
Heart Valve / Implantable
defibrillator
Definition
• Diagnosis, prevention, monitoring, treatment or
alleviation of a disease, injury or disability, or
• Investigation, replacement or modification of the
anatomy or physiological process, or
• Control of conception and
• Principal mode of action not pharmacological,
immunological or metabolic
5
28/09/2012
LEY Nº 29459 del Peru
LEY DE LOS PRODUCTOS FARMACÉUTICOS, DISPOSITIVOS MÉDICOS Y PRODUCTOS SANITARIOS
Artículo 1.- Objeto de la Ley
La presente Ley define y establece los
principios, normas, criterios y exigencias
básicas sobre los productos farmacéuticos,
dispositivos médicos y productos sanitarios de
uso en seres humanos, en concordancia con la
Política Nacional de Salud y la Política
Nacional de Medicamentos, las cuales deben
ser consideradas por el Estado prioridades
dentro del conjunto de políticas sociales que
permitan un acceso oportuno, equitativo y con
calidad a los servicios de salud.
LEY Nº 29459 del Peru
LEY DE LOS PRODUCTOS FARMACÉUTICOS, DISPOSITIVOS MÉDICOS Y PRODUCTOS SANITARIOS
Artículo 4.- Definiciones
3. Dispositivo médico: Cualquier instrumento, aparato,
implemento, máquina, reactivo o calibrador in vitro, aplicativo
informático, material u otro artículo similar o relacionado, previsto
por el fabricante para ser empleado en seres humanos, solo o en
combinación, para uno o más de los siguientes propósitos
específicos:
a) Diagnóstico, prevención, monitoreo, tratamiento o alivio
de una enfermedad.
b) Diagnóstico, monitoreo, tratamiento, alivio o ompensación
de una lesión.
c) Investigación, reemplazo, modificación o soporte de la
anatomía o de un proceso fisiológico.
d) Soporte o mantenimiento de la vida.
e) Control de la concepción.
f ) Desinfección de dispositivos médicos.
6
28/09/2012
Essential Requirements
• Safety and performance
Design & construction “state of the art”
- Chemical, physical, biological hazards
- Infection and microbial contamination
- Interaction, interference with other equipment
- Dependence on energy source and software
- Accuracy, stability, specificity of measurement
and diagnostic instruments
Basic Principle
• Risk/benefit analysis
- Acceptable risks when weighted against benefits to
the patient
- Compatible with high level of protection of health
and safety
• Risk reduction
- Elimination or reduction as far as possible
(safe design and construction)
- Protection measures
- Information about residual risks
7
28/09/2012
Basic Principle
• Clinical evaluation
- Required for all medical devices
- Critical analysis of clinical data
- Demonstration of conformity with Essential
Requirements
Scientific literature
Clinical investigations (GCP)
Required for implantable and class III MD
Subject to national notification/approval
Basic Principle
• Quality management system (QMS)
- Consistent compliance with regulatory
requirements
• (Voluntary) harmonized standards
- Presumption of conformity with Essential
Requirements
- ISO, IEC, CEN, CENELEC
8
28/09/2012
Basic Principle
• Conformity assessment procedure
- Self-certification (only low-risk MD)
- Third-party certification (for class IIa, IIb, III)
Notified Bodies
Designated and monitored by competent authorities
Assessment of QMS and design dossier (class III) or
technical file (class IIa, IIb: sampling)
Prior assessment of changes to QMS or MD design
Periodic surveillance inspections of manufacturer
Certificates with limited validity / renewal
Basic Principle
• Labeling
- Label
- Instructions for use
- CE-marking
• Registration and Listing
- Manufacturers / authorized representatives
- MD of class I
9
28/09/2012
Where to adjust the balance
between both necessities?
• Pre-market control
- risk related classification
- fast introduction of innovation
• Post-market control
- surveillance
- vigilance
Post-market safety
• Obligations of manufacturers
- Post-market surveillance plan, incl. post-market
clinical follow-up
- Reporting of serious incidents to CA
- Application of Field Safety Corrective Actions
(FSCA)
- Communication of FSCA to users by means of
Field Safety Notice (FSN)
10
28/09/2012
Post-market safety
• Responsibilities of competent authorities
- Central recording and evaluation of reported
incidents and FSCA
- Information sharing between competent
authorities (NCAR system)
- Market surveillance
◦ Measures against non-compliant MD
◦ Measures against dangerous products
Strengths
• Flexibility
• Timeliness
• Cost-effectiveness
• Balance between pre- and post-market
control
• Manageable for SMEs
11
28/09/2012
Areas for improvement
• Oversight of 70+ Notified Bodies
• Designation and monitoring
• Uniform standards of conformity
assessments
Areas for improvement
• Clinical investigations
• Introduction of the concept “sponsor”
• Coordination of technical assessment for
multi-national CI
12
28/09/2012
Areas for improvement
• Post-market safety
- Consistent and timely reactions to safety
issues
- Coordination of analysis of serious incidents
and market surveillance activities
Areas for improvement
• Transparency
- Economic operators and medical devices
- Summary device information
- Traceability of devices (UDI)
- Internet sales
13
28/09/2012
Overview and status
of GHTF
Global Harmonization Task Force
Call for Harmonization
The call for harmonization of regulatory
approaches is coming from many sectors :
• Governments
• Industry
• Public
14
28/09/2012
Why Harmonize?
• Regulatory harmonization should :
• Provide consistent application of regulatory
principles and approaches
• Improve regulatory system effectiveness
and efficiency
• Reduce duplication
• Rationalize time and costs
• Allow new products/technologies to enter
the market place
• Create transparent regulatory processes
Potential Challenges to
harmonization
• Differences in delegation of regulatory
authorities between levers of government
within a country
• Geo-political issues
• Consistency in the degree of
implementation
15
28/09/2012
Harmonization of
Medical Device Regulations
• Harmonization is consistent with the
policies of many regulatory authorities
• Regulatory programs are expected to :
• use available international
standards/guidelines as basis for technical
regulations
• proactively influence their development, as
appropriate
• Consult with stakeholders/public
Overview
• GHTF(Global Harmonization Task Force)
• Informal grouping of medical device
regulators and industry
• Began in 1992 with Canada, European Union,
Japan, USA and Australia as founding
members
• Currently consists of a Steering Committee, 5
Study Groups and several Ad Hoc Groups
• Has links with several partners, including :
ISO, IEC, WHO, PAHO, AHWP
16
28/09/2012
Overview
• Working to reduce or eliminate technical
differences in regulatory requirements and
practices
• GHTF conferences and commenting on draft
guidance documents
• Participation is broadening
• “Participating members”
• “Observers”
Purpose
• To encourage convergence in regulatory
practices related to ensuring the safety,
effectiveness / performance, and quality of
medical devices, promoting technological
innovation and facilitating international trade
and
• To serve as an information exchange forum through
which countries with medical device regulatory
systems can benefit from the experience of other
members.
17
28/09/2012
Basic Principles
• Serves as an information exchange forum
• Countries with medical device regulatory
systems under development can benefit
from others’ experience
• May pattern their practices upon those of
GHTF founding members
• Avoid unnecessary (new) regulatory
requirements
• Wasteful for governments and industry
• Delays technologies to the patient bedside
Organizational Structure
ISO, IEC
Steering
Committee
Latin American
Harmonization
Working Party
Study Group 3
Quality system
requirements
Study Group 5
Clinical evidence
PAHO
GMDN Agency
Asian Harmonization
Working Party
Study Group 1
Regulatory systems
Premarket assessment
WHO
Study Group 2
Vigilance reporting
Market surveillance
Study Group 4
Quality systems
auditing
ISO TC/210
18
28/09/2012
Steering Committee
• Provides policy direction and strategic planning,
and assigns and oversees technical work initiatives
• Chair rotates between regions every three years
• Regulator chair; industry vice-chair
• Chair provides Secretariat
• US FDA (CDRH) maintains the GHTF website and
records
• Meets twice/year and regular bi-monthly
conference calls
• Operates by consensus
Study Groups
• Work plans approved by Steering Committee
• Volunteer experts appointed by Founding
Member national regulators and industry
associations
• Meet face-to-face 2-3 times/years
• Work by E-mail between meetings
19
28/09/2012
Study Groups
Study groups are the engine of GHTF
guidance development ( almost 40 posted)
• SG1 : Pre-market conformance
• SG2 : Post-market vigilance/surveillance
• SG3 : Quality Systems
• SG4 : Auditing
• SG5 : Clinical effectiveness
Special Topics:
Ad Hoc Working Groups
• Medical Device software
• Combination Products
• Training
• Global Regulatory Model
• Global Medical Device Nomenclature
• Unique Device identifiers
• GHTF Administrative processes
20
28/09/2012
Strategic goals
• Emerging regulatory challenges
• Implementing guidance documents
• Mutual acceptance of common data by
regulators
• Evolving regulatory systems
• Communications
• Organization/infrastructure
Accomplishments To Date
• Risk-based classification system
• Common definitions and vocabulary
• Global Medical Device Nomenclature
• Technical (science) requirements
• Format and content of marketing applications
(STED)
• Assessment and review practices
• Post-market activities
• Quality Management Systems requirements
and audits
• Use of international standards
21
28/09/2012
GHTF Successes To Date
• Adverse event reporting
• The electronic national Competent Authority
Report(NCAR) system
• ISO 13485 and FDA Quality system
Requirements
• Auditing strategies and format finalized
• Summary Technical Documentation for
Demonstrating Conformity to the Essential Principles
of Safety and Performance of Medical Devices (STED)
• GHTF model served as basis of Australian system!
Taking the Task Force Forward
• Expansion
• Guidance Implementation
• New Challenges
22
28/09/2012
Expansion
• Work with AHWP, Latin American Countries, ISO,
IEC and others who share the GHTF goals
• GHTF Training Plan
• Invitation has been extended inviting
organizations to become training partners
• Continue to work with APEC on training
• Involve other countries
• Translate guidance documents into other languages
• Join National Competent Authority Report
system(NCAR)
• Adopt guidance with feedback to GHTF
Implementation
• Implementation of guidance documents
• Direct adoption of documents by regulatory authorities
• Single QS audits used for multiple jurisdictions
• Canada-Australia
• Canada-USA Pilot
• Improve operation and expand membership of
NCAR
• Adoption of GHTF Model as the regulatory
framework for certain Asia economies
23
28/09/2012
New Challenges
• Definition and regulation of “combination products”
• Training strategy for countries with no regulatory
framework
• Expanded participation
• Asia Harmonization working Party
• Latin American Harmonization WP
• ISO
• IEC
• WHO
• Additional elements of global regulatory model
• Global Medical Device nomenclature system
GHTF Model
• Guidance documents available in English on
the GHTF website: www.ghtf.org
• Links provided to translated documents
• PAHO translated into Spanish and Portuguese
• Training on the GHTF model and guidance
documents
• APEC sponsored
• Training Partners Initiative
24
28/09/2012
The Future is Now
• The GHTF has accomplished much
• The time has come to build on this
foundation and truly move toward the
realization of global harmonization
Introduction and
Perspective of AHWP
Asia Harmonization Working Party
25
28/09/2012
Overview
• AHWP was established as a non-profit
organization in 1998: www.ahwp.info
• AHWP is an informal regional forum
comprising of both government regulators
and industry representatives from member
economies in Asia
• AHWP is a Liaison Member of GHTF
Objectives
• To forge a common direction for
harmonization of medical devices
regulation in Asia
• To encourage increased understanding
on the benefits of harmonization
• To facilitate a linkage with GHTF
• To encourage active participation by all
Asian Economies
26
28/09/2012
Objectives
• To provide a forum for discussion and
training, facilitate information exchange,
initiate projects and provide platform for
implementation of harmonization among
regulators and industry groups in Asia
Members (21 Economies)
Myanmar
Korea
Brunei
Darussalam
Abu Dhabi
India
Chinese
Taipei
PR of China
Malaysia
Indonesia
Singapore
Chile
Jordan
Vietnam
Cambodia
Philippines
Laos
Hong Kong
China
Thailand
Kingdom of
Saudi Arabia
Pakistan
South Africa
27
28/09/2012
Structure
AHWP
Chair, Co-Chair, Secretariat
AHWP TC
Chair, Co-Chair, Secretariat
WG01
WG02
Pre-Market
Submission
Post-Market
Surveillance
WG01a
IVDD
WG03
Quality
Management
System
WG04
WG05
Quality
System Audit
Clinical
Evidence
Special Task
Group (STG1)
WG06
Capacity
Building &
Training
Special Task
Group (STG2)
Terms of Reference
• To work towards building a common
regulatory consensus based on acceptance
of international standards as the chief means of
ensuring product safety and assurance
• To move towards recognition of a common audit
that can be accepted throughout the Asian
region
• To work with the GHTF in technical
harmonization efforts and seek formal
representation and participation at GHTF
Steering Committee & Study Groups
28
28/09/2012
Terms of Reference
• To work towards a harmonized system of
medical device vigilance reporting for
adoption within the region and
information sharing
• To facilitate the process of regional
implementation of APEC initiatives for
medical devices sector
Harmonized Regulatory System in Asia
Pre-Market
• Definition
• nomenclature
• CSDT
• Essential Principles
• Standards
• Quality System
• Clinical evidence
• Conformity Assessment
• …………
Placement on Market
• Registration/licensing
• Advertisement & claims
• ……..
Post-Market
• Surveillance & vigilance system
• Usage
• Adverse Event Reporting
• Information sharing network
• ………..
29
28/09/2012
Accomplishments
• Comparative study on regulatory systems in Asian
Member Economies
• Adoption of
• GHTF definition of medical device
• Medical device classification & classification rules
• Nomenclature system
• Accepted as a Liaison Members of GHTF
• Cooperation/collaboration with international bodies
- GHTF, WHO, APEC(ongoing)
• Wider participation - Saudi Arabia, South Africa,
China, India(new members)
• AHWP website as a main communications tool
Accomplishments
Recommendations from the Comparative study
• Establish a clear & stated national policy as the basis and
framework for medical devices regulatory system
• Adopt definition classification of medical devices
• Use a region-wide nomenclature for medical devices
• Establish a comprehensive database and common
reporting format to monitor and document adverse incidents
• Assist each other in understanding, adapting and adopting
GHTF recommendations
• Build the capacity of the regulatory authorities & industry
players
30
28/09/2012
Current Tasks
At AHWP level
• Discussion with GHTF on AHWP-GHTF Collaboration
• Discussion with WHO on AHWP-WHO Collaboration
• Continue working towards enlarging the participating
economies
• Organizing training programs
At TC level
• Strengthening its organization
• Inviting representative from Members Economies to join WGs
• Planning and carrying out specific activities for WGs
Current Tasks
Tasks currently undertaken by WGs & STG
Work Group
WG01
Current Task
WG01a
CSDT
Conformity Assessment
IVDD
WG02
Safety Alert Dissemination System (SADS)
WG03
To be determined
WG04
To be determined
WG05
To be determined
WG06
Diploma in MD Regulation in collaboration with
Northeastern University, Boston, USA
STG
(Nomenclature)
Special Task to resolve nomenclature issue with GMDN
STG
(Legal Entity)
Special Task to set up AHWP Administration service Ltd.
31
28/09/2012
Strengthening AHWP
• Gap analysis
• What we have done/achieved vs what we want to
do/achieve
• A strong organization is required
• Major issues to strengthen our organization
• Lack of infrastructure - to assist Member
Economies to adopt AHWP’s recommendations into their
national systems
• Lack of expertise - to assist AHWP in the harmonization
effort
• Lack of financial support - to carry out planned activities
Strengthening AHWP
• Enlarge the participating economies
• Strengthen TC and WGs
• Organize training programs
• Establish effective communications network amongst
Member Economies
• Seek involvement of experts from professional/international
bodies and academia
• Seek budgetary and suitable GHTF recommendations
• Adopt and adapt suitable GHTF recommendations
• Assist each other in understanding, adapting and adopting
GHTF recommendations
32
28/09/2012
Setting up permanent Secretariat
• AHWP an a nonprofit organization needs to
registered a legal entity
• Set up AHWP Administration Service Ltd. In
Hong Kong
• Finance management for AHWP Activities
• Fix office location of permanent secretariat in
Hong Kong
Muchas Gracias!
33