Core Elements of Medical Device Regulatory Systems in …iom.nationalacademies.org/~/media/Files/Activity Files/Global... · Core elements of medical device regulatory systems in

Core elements of medical device regulatory systems in developing countries

4-Mar-11

Institute of Medicine

Washington, D.C.; 2-3 March 2011

M. Gropp; Medtronic, Inc., Minneapolis, USA

Core Elements of Medical Device Regulatory

Systems in Developing Countries

Strengthening Regulatory Systems in Developing Countries

IOM_Core_Elements_Med_Dev_Reg_Dev_Countries_March11_Gropp.ppt; All rights reserved


4-Mar-11 2

• General overview

• Scope

• Current situation

• Focus on regulation, not reimbursement, funding, procurement,

or health technology assessment

• Not covering in vitro diagnostic medical devices

• High level overview, risks of over-generalizing

• Speaking in personal capacity

Introduction



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Differences between Medical Devices and Drugs

Generally little user interactionTend to require significant user

interaction

Tend to differ only in molecular

structure, active site, mode of app.

Heterogeneous group; range from

tongue depressors to artificial hearts

Administered by mouth, skin, eyes,

lungs, or by injection; act through

metabolic, pharmacologic, or

immunologic means

Most act through physical interaction

with body or body part

Pure molecules; based on

pharmacology and chemistry; now

encompassing biotechnology, genetic

engineering, etc.

Physical objects; complex components

and assemblages; generally based on

mechanical, electrical, and materials

engineering

DrugsMedical Devices



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Differences between Medical Devices and Drugs

Typically short half-life in bodyDuration and nature of exposure varies

widely

Very large multi-national companies

dominate

Over 80% small and medium sized

enterprises

No service or maintenanceSome require service and repair, mfr.

technical training and support

Long market lifeShort market life (~ 18-24 months)

Discovered in lab-based research

processes

Invented and designed; often with

involvement of physician users

DrugsMedical Devices



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Source: US FDA CDRH 2005 Strategic Plan (modified)

Diversity of medical devices



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Definition – Global Harmonization Task Force

“‘Medical device’ means 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 …

Source: GHTF/SG1/N29R16:2005; Information document concerning the definition of the term ‘Medical device’;

Global Harmonization Task Force: At; http://www.ghtf.org/sg1/sg1-final.html (under revision)



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…. specific purpose(s) of:

• diagnosis, prevention, monitoring, treatment or alleviation

of disease

• diagnosis, monitoring, treatment or alleviation of or

compensation for an injury,

• investigation, replacement, modification, or support of the

anatomy or of a physiological process, …






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…. specific purpose(s) of:

• 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;






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…. 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”






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• In some countries, some ‘medical devices’ originally

regulated as medicines, e.g., sutures

• 1976 US medical device amendments to Federal Food,

Drug and Cosmetic Act

• Established device-specific provisions to Act and

authority for device-specific regulations

• Established devices Center

• Added to existing enforcement structures

• Comprehensive regulatory framework

• Risk-based classification

• Pre- and post-market controls

Early regulation of medical devices



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• In some European countries in 70s, regulatory focus on

certain aspects of ‘devices’ safety

• Sterility

• Electrical safety

• National standards

• Often required testing by government/test houses

• UK focus on supplier quality systems




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• European Community medical device directives in early to

mid-90s

• Based on Community legislation in other sectors

• Principle of mutual recognition and free circulation in

Internal Market

• Harmonized regulatory requirements

• Drew together elements of pre-existing national

approaches

• Regulatory controls proportional to risk-based

classification

• Established conformity assessment processes and

bodies




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• European Community medical device directives in early

90s (cont’d)

• Recognized international standards

• Regulatory responsibilities at Member State and EU

levels (but no central regulatory authority)

• Now apply throughout European Union and European

Free Trade Association Member States

• Model for international regulatory harmonization

guidance

• Growing US-EU regulatory cooperation




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• Similar evolution in Australia, Canada, and Japan

• Australia 1989 Therapeutic Goods Act amended to

cover all medical devices; 2002 amendments for

international harmonization

• Canada 1998 medical device amendments to federal

Food and Drugs Act

• Japan 2002 amendments to Pharmaceutical Affairs

Law

• Australia, Canada, EU, Japan, and USA are “Founding

Members” of Global Harmonization Task Force (GHTF)

• ~ 90% of global production (today)




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• Definition of ‘medical device’

• Registration of mfrs., importers, and distributors and devices placed on national market

• Risk-based classification system and controls

• Oversight/controls for clinical investigations

• Quality management system/GMP requirements

• Requirements for safety, performance, and quality

• Labelling requirements

• Clinical evidence requirements

• Recognition of standards

• Pre-market conformity assessment

• Post-marketing surveillance, adverse event reporting, field safety corrective actions/recalls

Elements of medical devices regulatory systems



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About 85 countries today regulate medical devices in

some fashion*:

• Countries with comprehensive regulatory systems

specific to medical devices (e.g., GHTF Founding

Members)

• Varying degrees of harmonization

• Countries with comprehensive advanced regulatory

systems

• Harmonized (e.g., Singapore, Chinese Taipei)

• Not harmonized (e.g., Brazil, Korea, Thailand)

Status of regulation of medical devices

* semi-arbitrary, imprecise, overlapping, categorization; illustrative examples only



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some way (cont’d):

• Countries with less advanced, less comprehensive un-

harmonized regulatory systems (e.g., China)

• Economies with harmonized, but not comprehensive,

regulatory systems (e.g., Hong Kong SAR)




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some way (cont’d):

• Countries with non-comprehensive regulatory controls

for some devices based on drugs regulations (e.g.,

India, Ethiopia)

• Countries with basic controls, e.g., registration of

importers and/or producers (e.g., New Zealand,

Bangladesh, Sri Lanka, some Caribbean, South and

Central America, and north Africa countries)

• Countries with no regulatory controls (e.g., sub-

Saharan Africa, central Asia)




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• Many new systems being developed and/or implemented

(e.g., Saudi Arabia, Malaysia, Indonesia, South Africa,

Russia, Pakistan, ASEAN, UAE)

• Slowly growing web of bilateral mutual recognition

agreements (e.g., EU-Switzerland, EU-Australia) and joint

assessments (e.g., US and Canada)

• In a few cases, acceptance of marketing authorization in

designated countries as evidence of substantial

conformity with importing country requirements (e.g.,

Mexico)




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World Health Organization

• Guidance for member states on medical device

regulation (2003) generally based on GHTF model

• Some procurement standards for some devices

• No direct role in device nomenclature

• First Global Forum on Medical Devices (Bangkok,

Sept. 2010) highlighted need for regulatory capacity-

building in less and least developed countries




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Conceptual qualitative overview of current national

medical device regulatory systems

Harm

onization (GHTF/AHWP)

Comprehensiveness

High

High

Low

Low



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medical device regulatory systems

Harm


Comprehensiveness

High

High

Low

Low

Hong Kong SAR

Pakistan

BangladeshIndia

China

USA

Australia

Singapore

New Zealand

Japan

CanadaEU, EFTA

Saudi Arabia

Thailand

Mexico Brazil

Notes:

• Position in clusters not necessarily significant

• Subjective assessment of many variables

• Variables not weighted

• Not all countries that regulate medical devices shown

Chinese Taipei

Korea

South Africa

Argentina Colombia



4-Mar-11 23


medical device regulatory systems – Trends

Harm


Comprehensiveness

High

High

Low

Low

Hong Kong SAR

Pakistan

BangladeshIndia

China

USA

Australia

Singapore

New Zealand

Japan

CanadaEU, EFTA

Saudi Arabia

Thailand

Mexico Brazil

Notes:

• Position in clusters not necessarily significant

• Subjective assessment of many variables

• Variables not weighted

• Not all countries that regulate medical devices shown

• Some countries moving faster than others and with

different paths

Chinese Taipei

Korea

South Africa

Argentina Colombia

?



4-Mar-11 24

• Regulatory systems for medical devices differ from those for medicines and other regulated products

• Regulatory controls proportional to risks, linked to device life cycle

• Medical device regulation more recent and evolving rapidly

• Development and production becoming more geographically widespread

• Wide range of capacity, comprehensiveness, and international harmonization among national regulatory systems

Conclusions

Documents

Core Elements of Medical Device Regulatory Systems in …iom.nationalacademies.org/~/media/Files/Activity Files/Global... · Core elements of medical device regulatory systems in