8/6/2019 Feigal 13485 Harmonization

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a report by

Dr s D av i d W F e i g a l , L a r r y G K e s s l e rand

Ronda A B a l h am

Former Director, Center for Devices and Radiological Health (CDRH) and Director, Office of Science and

Engineering Laboratories and Assistant to the Director, International Affairs Staff, CDRH, FDA

The Global Harmonization Task Force (GHTF) is a

voluntary international association comprising

regulatory authorities and representatives of industry

from the five founding members Europe, the US,

Canada, Japan and Australia. It is not a standards

development organisation and has no legal status.

Although there are no formal commitments toimplement the guidance documents, the members

have expressed the intent to assist in developing

documents and implementing them where possible

within their respective legal and regulatory systems.

The primary organisational goal is to provide a forum

for authorities and industry representatives to work

together to encourage convergence in those regulatory

practices related to ensuring the safety, effectiveness or

performance and the quality of medical devices and to

facilitating technological innovation. The GHTF also

serves as a means for information exchange through

which countries with emerging medical deviceregulatory systems are able to benefit from the

experience of those countries with already established

regulatory systems. In these instances, the GHTF hopes

that emerging regulatory systems will follow the

established GHTF models, will not levy additional

burdens on industry and will develop systems

compatible with other regulatory agencies.

To enhance the health of the public worldwide, the

GHTF has several objectives. The first of these is to

encourage development of a harmonised regulatory

environment, thereby allowing for better protection ofpublic health and facilitating the availability of

important new medical technologies while preserving

the right of participating members to address this

protection of public health by the regulatory means

considered most suitable. The second is to voluntarily

reduce regulatory differences and to eliminate any

unnecessary duplicative controls while maintaining the

safety, effectiveness and quality of medical devices. The

third objective is to facilitate the development of an

international post-market vigilance system that will

reduce the likelihood of repeated adverse events. The

last is to foster international co-operation betweencountries with established regulatory systems and

countries with developing regulatory systems.

The GHTF is currently organised into a steering

committee (SC) and four study groups (SGs). The SC

provides policy direction and strategic planning, assigns

technical work initiatives and provides oversight to the

various SGs. The SC is composed of four regulatory

authorities and four industry members from each of the

three founding geographic areas Europe (comprised

of the European Union (EU), the European FreeTrade Association and Switzerland), North America

and Asia. The chairmanship of the SC rotates among

the national regulatory authorities of the three

geographic areas with a term length of three years.

Currently, the chairmanship is held by the EU. To

support the GHTF chair, a GHTF vice chair is

designated from the regulated industry of the same

country as the chair. Providing support to the GHTF

chair and the SC are the executive secretariat, which

provides direct staff support and administrative duties,

and the permanent secretariat, which maintains a

current inventory of all completed and in-processdocuments and supervises the maintenance of the

GHTF website (www.ghtf.org). The executive

secretariat is from the same country as the chair and

rotates with the chair and vice chair while the

permanent secretariat service is provided by the US

Food and Drug Administration (FDA).

There are currently four SGs in GHTF each composed

of one or more representatives from each geographic

area with founding member status. The GHTF

attempts to maintain a balance between industry and

regulatory technical experts who represent differentdevice types or regulatory classes.

SG1 was initially tasked with comparing founding

member medical device regulatory systems and, from

that comparison, isolating the elements/principles that

may be suitable for harmonisation and those that may

present obstacles to uniform regulations. Additionally,

the SG is responsible for developing a standardised

format for pre-market submissions and harmonised

product labelling requirements. SG1 has developed

guidance documents that address essential principles of

safety and performance, labelling, the role of standards,device classifications and summary technical files for

pre-market documentation of conformity. If

implemented, SG1 recommendations may lead to

generally accepted definitions of what is considered to

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Current Issues

Dr David W Feigal is Former

Director of the Center for Devices

and Radiological Health, having been

appointed by the Commissioner of

the US Food and Drug

Administration (FDA) in 1999. He

came to the FDA in 1992 to head

the Division of Anti-Viral Drug

Products. In 1996, he was also the

Acting Director of the Anti-InfectiveDrug Division. From 1994 to 1997,

he was the Director of the Office of

Drug Evaluation IV. In the fall of

1997, he moved to the Center for

Biologics Evaluation and Research as

the Medical Deputy Director.

In September, 2002, Dr Larry G

Kessler was appointed Director of

the Office of Science and

Technology at the FDAs CDRH. In

this position, he directs the efforts

of the laboratories of CDRH and

the Standards Coordination

Program. Dr Kessler first joined the

FDAs Center for Devices andRadiological Health as the Director

of the Office of Surveillance and

Biometrics in June 1995. He has

published over 100 peer-reviewed

journal articles, as well as

numerous book chapters and

government reports. His research

has concentrated on applications of

quantitative methods and health

services research to problems in

surveillance and public health.

Captain Ronda A Balham is Assistant

to the Director of International

Affairs Staff at the CDRH. She is also

the permanent secretary to theGlobal Harmonization Task Force

(GHTF). From 2000 to 2002 she

was a Mansfield Fellow, spending a

year working in medical device-

related divisions of the Ministry of

Health, Labour and Welfare in

Tokyo, Japan. Dr Balham holds a

Doctor of Optometry degree from

The New England College of

Optometry. After graduation, she was

commissioned as a Lieutenant in the

US Navy and spent four years on

active duty as a clinical optometrist.

This was followed by a three-year

tour at the National Naval Medical

Center in Bethesda, MD, where she

was the Director of the MedicallyIndicated Contact Lens Clinic.

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Global Harmonisat ion of Medica l S tandards

be a medical device; provide harmonised risk-based

classifications; streamline preparation of summary

technical files, acceptable to authorities in many

markets; and allow greater reference to and use of

international standards.

SG2 is charged with the task of reviewing currentadverse event reporting, post-market surveillance and

other forms of vigilance for medical devices, as well as

undertaking an analysis of different requirements

among founding member medical device regulatory

systems to help define requirements for a common

medical device vigilance system and to provide an

international protocol to define and facilitate the

transmission of vigilance information on a global basis.

SG2 members are also participating in a global

exchange of adverse event reports. The basic mission of

a vigilance and post-market reporting system is to

improve the protection of health and safety of patients,device users and others by reducing the likelihood of

the same type of adverse incidents being repeated in

different places at different times.

SG3 is responsible for the task of examining existing

quality system requirements in the founding member

regulatory systems and identifying areas suitable for

harmonisation. Due to the close co-operation of SG3

with the International Organization for

Standardization (ISO) working group on the

development of ISO 13485:2003 (Medical devices

Quality management systems Requirements forregulatory purposes), the GHTF recently published a

statement on 13485:2003 believing it to be an

adequate standard for a medical device quality

management system. For the purpose of regulating

medical devices, GHTF believes that the generic ISO

9001:2000 is insufficient by itself and ISO 9001:2000

should not be required in addition to ISO

13485:2003. Countries considering incorporating

quality management system requirements directly

into their regulation and not citing ISO 13485:2003

verbatim are encouraged to harmonise their

regulation with ISO 13485:2003. Increased relianceon the recommendations found in SG3 final

documents on quality systems for the design and

manufacturing of medical devices, design control, and

process validation guidance for manufacturers will

form the basis for improved communication between

competent authorities, conformity assessment bodies

and manufacturers with a direct benefit of avoidance

of duplication of work and a reduction in costs.

SG4 has been charged with the task of examining

quality system auditing practices among the founding

members of the GHTF and developing guidancedocuments outlining harmonised principles for the

medical device auditing process. For patients and users

of medical devices, harmonised requirements and

processes for auditing manufacturer quality systems

would provide a high degree of assurance that only safe

and effective medical devices will be available.

Adoption of SG4 recommendations would reinforce

reliance on international standards as the basis for

placing devices on the market and reduce variations in

documentation requirements from one country to

another. SG4 recommendations could also provide abasis for confidence-building among authorities in the

results of audits conducted by others and provide more

consistent and predictable audits.

In October 2002, the SC of the GHTF proposed

several strategic goals for the next five years:

to encourage and support the timely identification

of opportunities to promote regulatory convergence

in addressing regulatory challenges including those

of emerging public health risks and new medical

technologies and to implement a process to identifythese new risks and technologies in order to achieve

regulatory convergence in their management;

to encourage the adoption of timely and clear

guidance suitable for implementation in national/

regional regulatory systems;

to evolve beyond convergence of regulatory

requirements to embrace mutual acceptance of

common data submissions, pre-market conformity

assessment (including clinical evidence) processes,

quality systems, quality systems auditing results anda broad sharing of post-marketing experience; and

for the GHTF SC to support and advocate the

adoption of a global regulatory model in their own

systems and those of other countries/regions.

Since its inception, the GHTF has been able to claim

numerous achievements. First amongst these is the

willingness of the founding members not only to find

compromise in the regulation of medical devices, but

to also adopt the GHTF model to the full extent of

their existing regulations. GHTF guidance documentshave been adopted by non-members such as Hong

Kong and Singapore and there has been high interest

in the programme by the Asian Harmonization

Working Party (AHWP) and the Pan American Health

Organization (PAHO).

The next several years will bring new opportunities

to the global harmonisation effort as new regulatory

challenges emerge from the development of new

technologies and new materials. There will continue

to be the opportunity to offer guidance to those

countries that are developing regulatory systems formedical devices as well as to facilitate access to the

global market for medical device manufacturers by

means of common principles and criteria for

assessment of regulatory practices.