Regulation Model

GHTF/AHWG(PD1)/N1R5

DRAFT

Title: Global Harmonization Task Force Medical Device Regulation Model

Authoring Group: Ad Hoc GHTF Regulatory Model Working Group

Endorsed by: The Global Harmonization Task Force

Date: 2 July 2009

The document herein was produced by the Global Harmonization Task Force, which is comprised of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.

Copyright © 2000 by the Global Harmonization Task Force

Global Harmonization Task Force Medical Device Regulation ModelGHTF Ad Hoc Working Group 2009

Table of Contents

CHAPTER 2 INTRODUCTION...................................................................................5

CHAPTER 3 RATIONALE, PURPOSE AND SCOPE................................................5

Rationale.................................................................................................................................................................5

Purpose....................................................................................................................................................................6

Scope........................................................................................................................................................................6

CHAPTER 4 REFERENCES......................................................................................6

SG1...........................................................................................................................................................................6

SG2...........................................................................................................................................................................7

SG3...........................................................................................................................................................................7

SG4...........................................................................................................................................................................7

SG5...........................................................................................................................................................................8

ISO Standards........................................................................................................................................................8

CHAPTER 5 DEFINITIONS........................................................................................8

CHAPTER 6 EVOLUTION OF THE GHTF MODEL...................................................8

CHAPTER 7 THE GHTF MODEL OVERVIEW.........................................................10

CHAPTER 8 CHARACTERISTICS OF THE GHTF MODEL....................................12

The Global Medical Device Regulatory Perspective of the GHTF Model......................................................12

GHTF Model Dynamics and Interrelationships................................................................................................12

Application to Central or Decentralized Regulatory Administrations...........................................................13

Use of GHTF Documents by Countries or Economies with Established Regulatory Systems or Emerging Systems..................................................................................................................................................................13

Roles and Responsibilities of National Competent Authorities (NCA), Conformity Assessment Bodies (CAB), and Manufacturers..................................................................................................................................13

CHAPTER 9 ELEMENTS OF THE GHTF MODEL..................................................14

The fundamental, harmonized elements of the GHTF Model.........................................................................14

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Other important elements of the GHTF Model.................................................................................................14

Additional regulatory elements not within the scope of the current work of the GHTF..............................14

CHAPTER 10 GRAPHIC REPRESENTATIONS OF THE GHTF MODEL...............15

Flow Chart Format..............................................................................................................................................15

GHTF Model: Study Groups 1 and 5 documents..............................................................................................16

GHTF Model: Study Groups 2, 3 and 4 Documents.........................................................................................17

Combined Representation of the GHTF Model................................................................................................18

CHAPTER 11 SUPPLEMENTAL GHTF MODEL INFORMATION...........................19

11.1 Premarket Evaluation..................................................................................................................................19

11.2 Postmarket Surveillance/Vigilance.............................................................................................................20

11.3 Quality Systems............................................................................................................................................22

11.4 Auditing.........................................................................................................................................................23

11.5 Clinical Safety/Performance........................................................................................................................24



Preface

The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device Regulatory Authorities and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution, translation or use of this document. However, incorporation of this document, in part or in whole, into any other document does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.



Chapter 2 Introduction

The objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical devices in order to facilitate trade whilst preserving the right of participating members to address the protection of public health by those regulatory means considered the most suitable.

The primary way in which the GHTF achieves its goals is through the production of a series of guidance documents that together describe a global regulatory model for medical devices. The purpose of such guidance is to harmonize the conformity assessment principles, procedures and documentation that apply to medical devices under each jurisdiction’s regulations. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.

This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities, Conformity Assessment Bodies and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of Regulatory Authorities to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry.

The GHTF Steering Committee Ad Hoc Working Group on the GHTF Medical Device Regulatory Model supports and encourages regulatory harmonization but recognises that Regulatory Authorities may have to consider their local needs when they introduce new medical device regulations. However, Regulatory Authorities that are developing regulations for medical devices, or amending existing ones, are encouraged to consider the adoption of the regulatory system described in this document, as this will help to reduce the diversity of systems world-wide and facilitate the process of harmonization.

The GHTF Steering Committee Ad Hoc Working Group on the GHTF Medical Device Regulatory Model has prepared this guidance document. Comments or questions about it should be directed to either the Chairman or Secretariat of the GHTF Steering Committee whose contact details may be found on the GHTF web page1.

Chapter 3 Rationale, Purpose and Scope

Rationale

Medical device regulatory systems are primarily intended to help protect and promote the public health and safety. Public trust and confidence in these systems depends upon the safety and performance of medical devices throughout their life-cycle.

1 www.ghtf.org



Regulatory authorities implement laws, regulations, guidance, or policies and

procedures governing aspects of the medical device life-cycle. Regulatory Authorities determine the extent and complexity of these regulatory controls. A clear and coordinated system of regulatory controls throughout the medical device life-cycle, in conjunction with the manufacturer’s systems, facilitates safety and performance of medical devices. Use of harmonized, coordinated controls expands the public health benefits, enables global leveraging of regulatory resources, and reduces burdens to the regulated industry.

The GHTF has created guidance documents that together have described a harmonized medical device regulatory model. The GHTF Steering Committee directed that a current, single document is needed to describe that model in all its parts.

Purpose

To describe the GHTF Medical Device Regulatory Model based upon:

Guidance documents created by the GHTF Study Groups

GHTF guidance documents under development

International standards

Important elements of a regulatory model considered by the GHTF Steering Committee or Study Groups but not proposed as work items for development

This guidance is intended to integrate the existing GHTF guidance documents and show their relationship to the medical device life-cycle.

Scope

This document provides an overview of the GHTF Regulatory Model. It describes the basic elements but it does not describe those elements in detail. The details are described in the referenced GHTF Study Groups’ guidance documents.

Be advised that the referenced documents may be updated from time to time and new documents will be added. The Regulatory Model document may then require amendment. The public should use the most current GHTF documents as listed in www.ghtf.org.

Chapter 4 References

GHTF final documents

SG1

GHTF/SG1/N044:2008 Role of Standards in the Assessment of Medical Devices.GHTF/SG1/N015:2006 Principles of Medical Devices Classification.GHTF/SG1/N029:2005 Information Document Concerning the Definition of the Term

‘Medical Device’.GHTF/SG1/N041:2005 Essential Principles of Safety and Performance of Medical Devices.


http://www.ghtf.org/


GHTF/SG1/N043:2005 Labelling for Medical Devices.GHTF/SG1/N040:2006 Principles of Conformity Assessment for Medical DevicesGHTF/SG1/N011:2008 Summary Technical Documentation for Demonstrating Conformity to

the Essential Principles of Safety and Performance of Medical Devices (STED)GHTF/SG1/N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices

Classification GHTF/SG1/N046:2008 Principles of Conformity Assessment for In Vitro Diagnostic (IVD)

Medical Devices GHTF/SG1(WD)/N05 Registration of Manufacturers and other Parties and Listing of

Medical Devices

SG2

GHTF/SG2/N54:2006 Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices

GHTF/SG2/N57:2006 Medical Devices Post Market Surveillance: Content of Field Safety Notices

GHTF/SG2/N79:2006 Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form

GHTF/SG2/N47:2005 Review of Current Requirements on Postmarket Surveillance GHTF/SG2/N68:2005 Summary of Current Requirements for Where to Send Adverse Event

Reports GHTF/SG2/N38 Application Requirements for Participation in the GHTF National

Competent Authority Report Exchange Program GHTF/SG2/N6R3 Comparison of the Device Adverse Reporting Systems in USA, Europe,

Canada, Australia & Japan GHTF/SG2/N8R4 Guidance on How to Handle Information Concerning Vigilance Reporting

Related to Medical Devices GHTF/SG2/N16R5 Charge & Mission StatementGHTF/SG2/N21:1999 Adverse Event Reporting Guidance for the Medical Device

Manufacturer or its Authorized Representative. archived

SG3

GHTF/SG3/N15:2005 Implementation of Risk Management Principles and Activities Within a Quality Management System

GHTF/SG3/N99-10 (Edition 2) Quality Management Systems - Process Validation Guidance

SG4

GHTF/SG4 N28R4:2008 Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements

GHTF/SG4/N30:2006 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy

GHTF/SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports

GHTF/SG4 (00) 3 Training Requirements for Auditors (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 2)



SG5

GHTF/SG5/N2:2007 Clinical Evaluation GHTF/SG5/N1:2007 Clinical Evidence – Key Definitions and Concepts

ISO Standards

ISO 9000: Quality Management Systems - Fundamentals and Vocabulary ISO 14971:2007 Medical Devices – Application of risk management to medical devices

Chapter 5 Definitions

Life-cycle: all phases in the life of a medical device, from the initial conception to final decommissioning and disposal (ISO 14971:2007)

Marketing: the distribution and/or use of a device in commerce (based on definition of Supplying to the Market)

Quality Management: coordinated activities to direct and control an organization with regard to quality (ISO 9000)

Product Realization: the process starting with planning and proceeding through determination of customer requirements and customer communication, design and development, purchasing, production and servicing, control of monitoring and measuring devices, and including delivery of the medical device (ISO 13485:2003)

Risk Management: the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971:2007)

Supply(ing) to the market: the making available, in return for payment or free of charge, of a device, other than a device intended for clinical or performance evaluation, with a view to distribution and/or use on the market (SG1(WD)/N065)

Other definitions are described in the referenced documents in Chapter 4.

Chapter 6 Evolution of the GHTF Model

The GHTF was conceived in 1992. The Study Groups independently initiated work plans and guidance until the GHTF Steering Committee was formed and GHTF procedures were established. The GHTF Study Group work plans in the 1990’s were not initiated based upon a documented GHTF model. Rather, it was the consensus of the GHTF members at the time that work should begin on several common aspects of the regulatory practices of the five founding members. New international standards affecting regulatory practices and the revision of regulatory systems of some of the founding members also catalyzed work in quality management systems and other aspects of the regulatory life-cycle.



GHTF guidance development has continued under five major regulatory groupings

including: Premarket Evaluation, Post-Market Surveillance/Vigilance, Regulatory Auditing, Quality Systems, and Clinical Safety/Performance. The GHTF members recognized these subject groups as areas common to each of their systems.

In order to help set the GHTF work program in an overall context; Study Group 1 posted for public view an overview of the overall GHTF program2. Study Group 2 similarly has produced integrated descriptions of their work program3. At a meeting of the GHTF Steering Committee in Kuala Lumpur, Malaysia in 2008 the Committee determined that an updated GHTF Model document should be produced. Such a document would, for example:

Clarify the current integration of the Study Group guidance into the model generally understood by the five founding members

Identify gaps in guidance and the need for any future work items Improve understanding of the GHTF guidance framework and be a basis for training Assist regulators in developing regulatory systems based on a GHTF harmonised

model Clarify the relationship of regulatory controls during the product life-cycle

2 This document, entitled Overview of the GHTF Work Programme, was developed by Study Group 1 (identified as N31R1). At the 2nd meeting of the Ad Hoc Procedures Group in February, 2000, it was decided that this document could be of great value in educating those not that familiar with the work of GHTF as to the scope of work of each Study Group. 3 See http://www.ghtf.org/sg2/sg2-guidance/index.html



CHAPTER 7 The GHTF Model Overview

Figure 1 illustrates the fundamental life-cycle of a medical device. The figure demonstrates that medical device development is a continuous process of concept, product realization, supplying to the market, marketing, and obsolescence or renewal as a modified product. The figure also illustrates the fact that there are relationships among the phases of the life-cycle. For example, experience gathered in the marketing phase feeds back into the design and testing of new products, product improvements, or corrective actions.

Figure 1: Product Life-cycle

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Figure 2 illustrates the application of regulatory processes to the life-cycle. The entire

cycle is subject to the regulatory processes of a Quality Management System, Risk Management, and Regulatory Auditing. Premarket regulatory controls such as Competent Authority or third-party review of summary technical files may apply during product realization. The product is then supplied to the market subject to regulatory controls such as registration of the manufacturer. Postmarket surveillance and vigilance controls and reporting apply during the marketing of the device. Many of these controls are described in GHTF documents.

Figure 2: Product Life-Cycle with Regulatory Aspects Applied

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Figure 3 displays the same information described in Figures 1 and 2 but in a linear

representation. Here the regulatory model is displayed as three primary steps including premarket, supplying to the market then postmarket. The regulatory activities within each stage are noted.

Figure 3: Product Life-Cycle, Linear Representation with Applied Processes

Regulatory Audit

Quality Management System - Risk Management

PremarketClassification – Conformity Assessment

Postmarket SurveillanceConformity Assessment (continued)

RegistrationListing

Essential PrinciplesStandards

Device SpecificationDesign Control

Design verification and validationClinical Evidence

STEDDeclaration of conformity

Adverse Event ReportingComplaint Management

Maintenance and Service Corrective and Preventive Actions

Postmarket clinical follow up

Chapter 1 Characteristics of the GHTF Model

The Global Medical Device Regulatory Perspective of the GHTF Model

The GHTF Model represents globally harmonized regulatory processes to be considered and applied at the federal, national, regional or economy level, as appropriate. Be aware that medical device life-cycle models described in non-GHTF publications may or may not be consistent with the GHTF Model. The non-GHTF models may address factors unique to a country or economy, or factors not addressed in a GHTF document.

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GHTF Model Dynamics and Interrelationships

The parts of the GHTF Regulatory Model are interrelated and dynamic. This is the nature of the medical device life-cycle. An event occurring in any point of the life-cycle may have a regulatory effect on other points in the cycle. Some of these interrelationships, e.g., postmarket surveillance reports leading to corrective actions and potential premarket reassessment, are described in the Study Group documents. The Model document in final form may be amended to describe these relationships in more detail. See http://www.ghtf.org/meetings/conferences/12thconference/slides/slides-gropp.pdf for a sample illustration of cycle interconnections.

Application to Central or Decentralized Regulatory Administrations

The GHTF Regulatory Model is comprised of interconnecting subsystems, e.g., premarket and vigilance/surveillance, which together describe a coordinated, harmonized regulatory program. The Model can be applied to centralized or decentralized regulatory systems. For example, the United States Competent Authority (FDA) currently is responsible for the national device regulatory activities while the European Union system uses private third-party Conformity Assessment Bodies for premarket activities and Competent Authorities for postmarket surveillance/vigilance.

Use of GHTF Documents by Countries or Economies with Established Regulatory Systems or Emerging Systems

The GHTF Regulatory Model describes an integrated system composed of many parts. The GHTF founding member countries and economies have progressed to a point where their systems are established in a form that basically coincides to the GHTF Model framework. Each member is adopting GHTF documents as opportunities to do so present themselves.

Some other countries and economies are building or revamping their regulatory systems. In doing so they are considering the GHTF Model and elements that are responsive to their specific needs. The Pan American Health Organization and the World Health Organization in publications have suggested step by step means of building a regulatory program based on the GHTF Model.

The building blocks of the GHTF Model for emerging systems typically begin with defining the articles to be regulated (i.e., definition of a medical device), registration of manufacturers and importers, labelling control, and surveillance mechanisms. Depending on resources and leveraged opportunities, programs are added such as quality systems, auditing, and a means of assuring safety and performance of products.

Roles and Responsibilities of National Competent Authorities (NCA), Conformity Assessment Bodies (CAB), and Manufacturers

The GHTF Model, and the GHTF documents upon which it is based, incur responsibilities for the stakeholders in the regulatory system, i.e., the manufacturer, NCA, and CAB. See

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http://www.ghtf.org/meetings/conferences/12thconference/slides/slides-gropp.pdf


http://www.ghtf.org/meetings/conferences/12thconference/slides/slides-gropp.pdf for a comparative table of some of these responsibilities.

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http://www.ghtf.org/meetings/conferences/12thconference/slides/slides-gropp.pdf


Chapter 2 Elements of the GHTF Model

The fundamental, harmonized elements of the GHTF Model

The key subsystems of the GHTF Model are (1) risk-based premarket controls, (2) a system of post-market vigilance and surveillance, (3) a quality management system and risk management process encompassing the life-cycle, and (4) a regulatory audit process to periodically assess conformity.

Other important elements of the GHTF Model

The Study Group documents describe in detail other important elements of the GHTF Model. Some of these include (1) harmonized definitions, (2) registration of manufacturers and listing of medical devices (3) applying clinical evaluation and clinical evidence during the life-cycle, (4) labelling, and (5) communications to users of medical devices.

Additional regulatory elements not within the scope of the current work of the GHTF

The GHTF has not identified as work items some regulatory aspects that exist in more than one of the five GHTF members. These include, for example, promotion and advertising of products, import/export procedures, and methods of regulatory enforcement.

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Chapter 3 Graphic Representations of the GHTF Model

Figures 1-3 in preceding chapters displayed the basic aspects of the GHTF Model in terms of the life-cycle of a medical device. The figures in this chapter present more detail of the GHTF Model. Figures 4 and 5 present the GHTF Model in a flow chart format. A flow chart format is used to show the progression and relationship of GHTF harmonized regulatory processes that occur in supplying a device to the market and during the course of marketing of the device. Figure 6 illustrates the GHTF Model in a combined, single figure manner that is equivalent to Figures 4 and 5. Figure 6 displays the Model using the device life-cycle as its central theme.

Flow Chart Format

Figures 4 and 5 display four levels of information as follows:

The yellow shaded boxes illustrate the fundamental GHTF Model processes in a sequential format. The processes include:

o Determining whether a product is a medical device based on whether its intended use meets the definition of a medical device

o Identifying, for regulatory purposes, the manufacturer, distributor, authorised representative and importer

o Determination the risk class of the deviceo Identifying the relevant essential principles of safety and performanceo Designing and manufacturing the device to meet the relevant essential

principles o Ensuring conformity to requirements based on risk class o Documenting technical information and submitting the documentation for

evaluation, as necessaryo Supplying the device to the market o Maintaining a vigilance and surveillance program and conformity to other

requirementso Conducting relevant risk management activities throughout the life-cycle o Ensuring safety and performance through appropriate enforcement and

oversight by the Competent Authority or their surrogate

The salmon shaded boxes illustrate the GHTF guidance that corresponds to the GHTF Model processes.

o Figure 4 illustrates the guidance developed by Study Groups 1 and 5.o Figure 5 illustrates the guidance developed by Study Groups 2, 3 and 4

The purple boxes illustrate regulatory questions that relate to the GHTF Model processes.

The green boxes refer the reader to other sections of this document where more information is provided for Study Groups 1-5.

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GHTF Model: Study Groups 1 and 5 documents

Figure 4

SPECIFY DEVICE’S INTENDED USE

DEVICECLASSIFICATION

IDENTIFY RELEVANT ESSENTIAL PRINCIPLES of

SAFETY & PERFORMANCE

DESIGN & MANUFACTURE DEVICE TOMEET ESSENTIAL PRINCIPLES

DEMONSTRATE COMPLIANCETHROUGH TESTING, MEETING

REQUIREMENTS OF STANDARDS, ORTHROUGH CLINICAL EVALUATION etc.

PLACE SAFE DEVICE ON THE MARKET

FULL TECHNICAL DOCUMENTATION

SUMMARISED TECHNICAL INFORMATION

ESSENTIAL PRINCIPLES of SAFETY & PERFORMANCE

LABELLING

DEFINITION OF A MEDICAL DEVICE

RISK BASEDCLASSIFICATION RULES

SUMMARY TECHNICALFILE

ROLE OFSTANDARDS

What is neededto ensure

saf ety & perf ormance?

How does the manufacturer

demonstrate conformity?

How does the manufacturer

demonstrate conformity?

What is amedical device?

MANUFACTURER’SPOST-MARKETSURVEILLANCE

VIGILANCEREPORTS

VERIFICATIONTHROUGH

INDEPENDENT AUDIT

(if required)

REGULATORY OVERSIGHTAND ENFORCEMENT

DOMESTIC & INTERNATIONAL

VOLUNTARY CONSENSUS STANDARDS

PREMARKETCONFORMITY ASSESSMENT

SG5: CLINICAL EVIDENCE

DEFINITION OF MANUFACTURER

AUTHORISED REPRESENTATIVE,

DISTRIBUTOR,IMPORTER

RISKMANAGEMENT

KEY

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GHTF MODEL PROCESSES

GHTF DOCUMENTS

REGULATORY QUESTIONS


GHTF Model: Study Groups 2, 3 and 4 Documents

Figure 5

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Combined Representation of the GHTF Model

As noted above, the backbone of this illustration is the life-cycle represented in blue.

Figure 6

Device Requirements/Intended use

Design Input/ Specifications

Design Verification

Pilot Production

Device validation

Market performance

Design

Manufacturing

Placing on the market

Definitions

The Essential Principles/Standards

QMS Design Control/Risk Analysis

QMS Design ControlRisk Assessment

QMS GMP

QMS Design Control/Risk assessment

QMS GMP

Te

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l In

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atio

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Device Classification

ST

ED

Conformity AssessmentApproval

Registation/ Licencing

Post Market Surveillance and vigilance

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Ma

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Labelling

Aud

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Product LifecycleStart

Medical Device Regulation Application

Process validation

SG1 SG3SG2 SG4

Clinical Evidence

SG5

Obslescence

QMS Service

Product LifecycleEnd

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Chapter 4 Supplemental GHTF Model Information

11.1 Premarket Evaluation

SG1 has been charged with supporting the convergence of medical device regulatory systems through the development of harmonized guidelines on elements of a global regulatory model. These elements include definitions of key terms such as ‘medical device’ and ‘manufacturer’; guidelines on essential principles of safety and performance, labeling; principles of classification and conformity assessment; and recommendations for summary technical documentation. In developing these guidelines, SG1 collaborates with other GHTF Study Groups in creating a global regulatory framework. It has additionally welcomed the contribution to its work of regulators and industry in other parts of the World.

Figure 7 illustrates the harmonized principles of the premarket phase addressed by Study Group 1. The reader should refer to the specific guidance documents referenced in this document and as posted on the GHTF web site.

Figure 7

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11.2 Postmarket Surveillance/Vigilance

SG2 is charged with the task of reviewing current adverse event reporting, post-market surveillance and other forms of vigilance for medical devices and performing an analysis of different requirements amongst countries with developed device regulatory systems with a view to harmonizing data collection and reporting systems.

SG2 has developed and updated harmonized guidance documents describing the data collection and reporting systems as illustrated previously in Figures 4 and 5. Figures 8a and 8b illustrate more detailed aspects of postmarket vigilance and surveillance and the associated Study Group 2 documents4.

Figure 8a: GHTF Model: Expanded Description of Study Group 2 Documents relating to Vigilance (Adverse Event Reporting by the Manufacturer to the Regulatory Authorities)

SG2 considers5 that Vigilance (Adverse Event Reporting by the Manufacturer to the Regulatory Authorities) is only a part – an important part - of Post-Market Surveillance. See Figure 8a. Other elements of Post-Market surveillance include:

4 See http://www.ghtf.org/sg2/sg2-guidance/sld001.html 5 See GHTF/SG2/N47:2005

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Market Surveys: Surveys of technical and clinical documentation Enforcement: Prohibit distribution via regulatory processes such as injunction,

product seizure, import detention, etc. Technical File Reviews: Review of Clinical and Technical Information for a

specific product Audits on Manufacturer: Inspection of manufacturer processes and procedures for

production and complaints handling Public Access to Information: Provide public access to certain specified

information taken and reported to the Agency Circulation of certain safety and regulatory information amongst National

Competent Authorities Recalls: Order, Monitor, and Classify product recalls, and disseminate written

communications to appropriate recipients Condition of Approval Studies: Review of product -associated clinical trials Review of Product Claims/Labelling: Labelling includes labels, IFU, promotional

material, websites Laboratory Testing: Testing of product for compliance with standards.

Guidance on the harmonization on most of these activities is either not necessary (e.g., Enforcement, Market Surveys), has been covered by other groups such as ISO or other GHTF Study Groups (e.g., Technical File Reviews, Audits, Laboratory Testing, Condition of Approval Studies). Comprehensive SG2 guidance is available for Vigilance. SG2 is currently working on definitions of Recall and other Field Safety Corrective Actions, and has already published guidance on the content of field safety notices.

Figure 8b – A pictorial representation of the relationship between Post Market Surveillance and Post-Market Vigilance.

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11.3 Quality Systems

SG3 is responsible for the task of examining existing quality system requirements in countries having developed device regulatory systems and identifying areas suitable for harmonization.

Figure 9 illustrates some of the harmonized principles for a Quality Management System as addressed by SG3.

Note that SG3 has worked closely with ISO TC 210 in the development of the ISO 13485 Quality Management System standard which offers the foundation for the management model supported by GHTF.

Figure 9

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11.4 Auditing

SG4 is charged with examining quality system auditing practices (initially among the founding members of the GHTF) and developing guidance documents laying harmonized principles for the medical device auditing process.

Figure 10 illustrates the harmonized principles as addressed by Study Group 4.

Figure 10

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11.5 Clinical Safety/Performance

SG5 is charged with promoting convergence of regulatory requirements for evidence of the clinical safety and performance of medical devices. The group concentrates on establishing harmonized definitions for commonly used terms as well as developing harmonized guidance on the content and format for clinical investigation reports and on how to conduct and document a clinical evaluation. The group works closely other GHTF study groups to review existing documents to ensure that terminology is consistent and interfaces are clear and that there is a consistent approach to broader GHTF initiatives.Figure 11 illustrates the harmonized principles addressed by Study Group 5.

Figure 11

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