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II II SimposioSimposio NacionalNacional de de la la CalidadCalidad 20122012

Seguridad de dispositivosmédicos y armonización mundial

Dr. Peter LeeConsultor coreanoDirector/Ingeniero jefeKATS-KTL

25 de Setiembre 2012

Chief Engineer and Director of the International Cooperation Center, KTL(Korea Testing Laboratory).

Engaged in diverse industrial fields such as a Medicaldevice control system, Certification, ISO management system, CE marking, Inspection/Audit and Electric &Electronic Products Safety/EMC test affairs from 1981in the Republic of Korea.

Earned a Ph. Doctorate of Technology policy at KoreaPolytec University, Master of Industrial engineeringat Soongsil Univ. and B.E of Electronics engineering at Chung-Ang Univ.E-mail: kmlee1452@hanmail.net

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El milagro de la República de Corea

A penas hace 50 años atrás. “Haremos cualquier cosa” le suplicaronCorea lo había perdido todo. los mineros al presidente de Alemania

Occidental.

http://youtu.be/PpznfKHNDnw El milagro de la República de Corea

K-Pop singers

PSY Gangnam Style + Idol Groups

Horse-Riding Dance Singer Psy

Girls Generation Dong Bang Shin Gi Wonder Girls

At NBC-TV “Today Show” in New York

http://youtu.be/9bZkp7q19f0 PSY - GANGNAM STYLE (강남스타일)

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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

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The Products US FDA regulate…

FDA Device Classification• Medical Device Classes:Class I - General Controls- Most exempt from premarket submissionClass II - Special Controls- Premarket NotificationClass III- Premarket Approval- Require Premarket Application

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GHTF MD Classification SystemCLASS RISK LEVEL DEVICE EXAMPLES

A (I) Low Risk 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 oralleviation of a disease, injury or disability, or

• Investigation, replacement or modification of theanatomy or physiological process, or

• Control of conception and

• Principal mode of action not pharmacological,immunological or metabolic

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LEY Nº 29459 del PeruLEY 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 PeruLEY DE LOS PRODUCTOS FARMACÉUTICOS, DISPOSITIVOS MÉDICOS Y PRODUCTOS SANITARIOS

Artículo 4.- Definiciones3. 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 aliviode una enfermedad.

b) Diagnóstico, monitoreo, tratamiento, alivio o ompensaciónde una lesión.

c) Investigación, reemplazo, modificación o soporte de laanatomía o de un proceso fisiológico.

d) Soporte o mantenimiento de la vida.e) Control de la concepción.f ) Desinfección de dispositivos médicos.

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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 tothe patient

- Compatible with high level of protection of healthand safety

• Risk reduction - Elimination or reduction as far as possible (safe design and construction)

- Protection measures - Information about residual risks

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Basic Principle• Clinical evaluation - Required for all medical devices - Critical analysis of clinical data- Demonstration of conformity with EssentialRequirements

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

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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) ortechnical 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

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Where to adjust the balance between both necessities?

• Pre-market control • Post-market control - risk related classification - surveillance - fast introduction of innovation - vigilance

Post-market safety • Obligations of manufacturers

- Post-market surveillance plan, incl. post-marketclinical 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)

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Post-market safety • Responsibilities of competent authorities

- Central recording and evaluation of reportedincidents and FSCA

- Information sharing between competentauthorities (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

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Areas for improvement • Oversight of 70+ Notified Bodies

• Designation and monitoring

• Uniform standards of conformityassessments

Areas for improvement

• Clinical investigations

• Introduction of the concept “sponsor”

• Coordination of technical assessment for multi-national CI

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Areas for improvement

• Post-market safety

- Consistent and timely reactions to safetyissues

- Coordination of analysis of serious incidentsand market surveillance activities

Areas for improvement

• Transparency

- Economic operators and medical devices

- Summary device information

- Traceability of devices (UDI)

- Internet sales

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Overview and status of GHTF

Global Harmonization Task Force

Call for Harmonization

The call for harmonization of regulatoryapproaches is coming from many sectors :

• Governments• Industry• Public

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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 ofimplementation

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Harmonization ofMedical 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

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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.

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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

Asian HarmonizationWorking Party

SteeringCommittee

ISO, IEC

WHO PAHO

ISO TC/210

GMDN Agency

Study Group 1Regulatory systems

Premarket assessment

Study Group 5Clinical evidence

Study Group 3Quality systemrequirements

Study Group 4Quality systems

auditing

Study Group 2Vigilance reportingMarket surveillance

Latin American Harmonization Working Party

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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

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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

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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

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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

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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

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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

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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 andPerspective of AHWP

Asia Harmonization Working Party

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Overview

• AHWP was established as a non-profitorganization in 1998: www.ahwp.info

• AHWP is an informal regional forumcomprising of both government regulatorsand industry representatives from member economies in Asia

• AHWP is a Liaison Member of GHTF

Objectives

• To forge a common direction forharmonization 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

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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 India Chinese Taipei

Vietnam Hong KongChina

Korea PR of China Cambodia Thailand

BruneiDarussalam

Indonesia Singapore Philippines Kingdom of Saudi Arabia

Abu Dhabi Chile Jordan Laos Pakistan

Malaysia

South Africa

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StructureAHWP

Chair, Co-Chair, Secretariat

AHWP TCChair, Co-Chair, Secretariat

WG01Pre-MarketSubmission

WG02Post-MarketSurveillance

WG03Quality

ManagementSystem

WG04Quality

System Audit

WG05Clinical

Evidence

WG06CapacityBuilding & Training

Special TaskGroup (STG1)

Special TaskGroup (STG2)

WG01aIVDD

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

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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• ………..

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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

AccomplishmentsRecommendations 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

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Current TasksAt 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 TasksTasks currently undertaken by WGs & STG

Work Group Current TaskWG01

WG01a

CSDTConformity AssessmentIVDD

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 withNortheastern 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.

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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

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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!