APEC Report-Funded June 13 -- 17, 2005

APEC Seminar on Harmonization of Medical Device Regulations

A. *Summary:* The Third APEC Seminar on Harmonization on Medical Device
Regulations, which took place in Bangkok, Thailand from June 13 -- 17,
2005, was an overwhelming success. This is one of two seminars funded by
APEC project number CTI17/2005T; the second seminar will take place in
Santiago, Chile in May 2006.

B. *Attendance:* A total of 201 regulators and industry representatives
attended the training seminar. Thirteen economies with developing
regulatory systems attended, including fifteen APEC economies and six
non-APEC economies. In addition, all five GHTF founding member economies
were represented by regulators and industry representatives. Economies
represented included:

i\) APEC economies with developing regulatory systems:

1\. Singapore (regulators and industry representatives)

2\. China (regulators and industry representatives)

3\. Malaysia (regulators and industry representatives)

4\. Thailand (regulators and industry representatives)

5\. Chinese Taipei (regulators and industry representatives)

6\. Republic of Korea (regulators and industry representatives)

7\. Indonesia (regulators and industry representatives)

8\. Philippines (regulators and industry representatives)

9\. Hong Kong (regulators and industry representatives)

10\. Chile (regulator only)

11\. Vietnam (regulator only)

12\. Russia (regulator only)

ii\) Non-APEC economies with developing regulatory systems:

1.  India (industry representatives)

> iii\) Non-APEC economies with developed regulatory systems:

1.  Sweden (industry representative)

2.  United Kingdom (industry representative)

3.  Norway (industry representative)

4.  Germany (industry representative)

iv\) GHTF founding members represented at event:

1\. United States (regulators and industry representatives)

2\. Australia (regulators and industry representatives)

3\. Japan (industry representative)

4\. Canada (industry representative)

5\. European Union (regulators and industry representatives)

Total attendance at the seminar was 201 regulators and industry
representatives broken down as follows:

Regulators or government officials from APEC economies with developing

regulatory systems: 69

Industry representatives from APEC economies with developing regulatory

systems: 104

Regulators from non-APEC economies with developing regulatory systems: 0

Others (trainers, government and industry representatives from GHTF

founding member economies, notified bodies, press, etc.): 28

Total: [201]{.underline}

C. *Trainers:* Twelve trainers were selected to conduct the training
program. All trainers were members of the various GHTF Study Groups. All
trainers were from GHTF founding member economies: four of these were
government regulators and the remaining eight were industry regulatory
experts. A list of trainers is attached.

D. *APEC Funding:* APEC authorized an expenditure of \$8,352 to fund
APEC regulator round-trip travel to Bangkok for selected APEC economies.
APEC provided \$7,500 in stipends to industry expert trainers, which was
evenly divided among the eight industry trainers (\$937.50).

*Funds Authorized Funds Spent*

APEC Regulators' airfare: \$8,352 \$4,085.20

Trainers' honoraria: \$7,500 \$7,500

Conference space, hosting and logistical costs: \$5,000 \$5,000

Publications and copying costs: \$5,000[^1] \$5,000

Consultant (including researcher) fees \$5,000 \$5,000

Consultant's secretary \$1,000 \$1,000

Equipment / Materials \$1,000[^2] \$1,000

Photocopying \$500 \$500

Communications \$2,000 \$2,000

Total [\$35,352]{.underline} [\$31,085.20]{.underline}

Positive Balance [\$4,266.80]{.underline}

Regulators from APEC economies, trainers, and Jeffery Gren as overseer,
were not charged a fee to attend the seminar. All other attendees were
charged US\$300.00 to attend to offset seminar costs.

The APEC proposal included cost sharing. Although APEC did not require
recordkeeping for cost sharing, below is an estimate:

Jeffrey Gren's advance trip: \$4,814

Jeffrey Gren's travel to Bangkok for the seminar itself: \$4,500

Eight industry trainers' fixed costs: \$21,500

Four government trainers travel costs: \$9,900

GHTF official's travel costs: \$2,500

Industry registration fees: \$9,000

In addition to the above travel costs, government and industry trainers
provided significant time, (preparation, travel and time at the seminar
itself) which represent significant value if computed based upon average
salary levels. Moreover, the U.S. Department of Commerce provided the
funding (\$2,499) for a hospitality reception on the evening of
Thursday, June 9.

E. *Program:* Attached is a program agenda. Below is a summary of the
regulatory training program.

> 1\) *Asian Harmonization Working Party (AHWP) organizational meeting.*
> AHWP discussed upcoming activities. A new chairman and vice chair were
> elected and agreement was reached for the next AHWP meeting to take
> place in Korea. The date of the next AHWP meeting has not been set.
>
> 2\) *Opening Plenary*. Jeffrey Gren of U.S. Department of Commerce
> made opening comments and outlined how the four-day seminar would be
> organized.
>
> Dr. Pahdee Pothisiri, Secretary General of Thai FDA welcomed the
> seminar attendees to Thailand and expressed the importance of global
> and Asian medical device harmonization. Following his remarks, Dr.
> Pothisiri conducted a press conference on the seminar, and an article
> on the event appeared in the Bangkok newspaper on July 14. This
> article is attached.
>
> Antonio Lacerda of the European Commission represented the Global
> Harmonization Task Force chair in his opening remarks. Dr. Lacerda
> stressed the importance of global regulatory training to promote
> harmonization and outlined recent GHTF accomplishments and future
> activities. Dr. Lacerda invited seminar participants to attend the
> next GHTF global meeting scheduled to take place in June 2006 in
> Lubeck, Germany.
>
> Jeffrey Gren concluded the opening plenary with a crystal ball
> forecast of the global regulatory environment twenty years in the
> future. Attached is Mr. Gren's Powerpoint presentation. Mr. Gren said
> that if his predictions come true, it will be due to continued medical
> devices global training and the cooperation of GHTF.
>
> During the opening plenary, each GHTF Study Group training chair,
> (Study Groups 1, 2, 3, and 4) provided a summary of their Study
> Group's mission. Johan Brinch of Study Group 5 provided a more
> detailed overview since that Study Group is relatively new and not
> covered by a separate training team.

3\) *Work groups.* Following the opening plenary, the seminar attendees
split into four work groups, and the four Study Group training teams
rotated to make presentations in three hour modules to each workgroup.
Below are the titles of presentations by each Study Group training team.

> *Study Group 1:* Essential Principles of Safety and Performance of
> Medical Devices; Principles of Medical Device Classification;
> Conformity Assessment; Summary Technical Documentation (STED); Roles
> of Standards in Assessment of Medical Devices; Global Medical Device
> Nomenclature (GMDN) System; In-Vitro Diagnostics and Global
> Harmonization.
>
> *Study Group 2:* Overview; Post Market Vigilance and Surveillance; TGA
> Guidelines - Post Market Activities, Guidance No. 11.
>
> *Study Group 3:* Session Overview; Introduction to SG3; Quality
> Management Systems, History and Evolution; ISO 13485:2000: An
> Overview; An Introduction to Design Verification and Validation;
> Process Validation Guidance; Implementation of Risk Management
> Principles & Activities within a Quality Management System; Guidance
> Documents.
>
> *Study Group 4:* Session Overview; Auditing by GHTF Founding Member
> Economies; Auditing GHTF Guidance Documents; Relationship Between
> Quality Systems and Auditing.
>
> 4\) *Special presentations.* Throughout the seminar there were three
> special presentation for all attendees:

a.  Presentation on FDA export certificates by Christine Nelson of the
    U.S. FDA

b.  Special Study Group 1 presentation on the GHTF Global Nomenclature

c.  Presentation on challenges to regulators due to new advances in
    medical technologies, by Michael Gropp of Guidant Corp.

5\) *Open Discussion.* Following the four Study Group training sessions,
there was a two-hour session during which each of the four work groups
discussed the obstacles for implementing GHTF guidance documents. This
session was the most significant "take away" of the seminar. An industry
and regulator co-chair was selected for each small working group and
each small working group made a presentation on their conclusion at the
closing plenary. Attached are the presentations of these four small
workgroups.

> 6\) *Seminar Close and Closing Comments.* The seminar was viewed as
> very successful due to expert coverage and representation from a large
> number of economies. There was strong support for the second seminar
> of this APEC-funded project to be held in Santiago, Chile in May 2006.

F. *Video*. APEC authorized the production of a videotape of the
seminar. Two copies of the video CDs were sent free of charge to each
APEC economy whether or not they were represented at the seminar.

G.  *Evaluation.* The feedback from the June 13 -- 17 APEC Seminar on
    Harmonization of Medical Device Regulations was extremely positive,
    and 43 attendees submitted evaluation forms. A copy of the
    evaluation form is attached, and responses are broken down as
    follows:

> ![](media/image1.wmf)

Excellent 15

Very Good 19

Good 9

Fair/Poor 0

H. *Next Steps:* Each attendee at the training seminar received a binder
with most presentations included. All presentations, with the exception
of "Challenges to Regulators from Advanced Medical Technologies," have
been posted on the Asian Harmonization Working Party (AHWP) website at
asiahwp.org. The presentation "Challenges to Regulators from Advanced
Medical Technologies" could not be posted because some of the slides
therein contained proprietary information not suitable for internet
posting. Attendees received a printed copy of this presentation. In
addition, the videotape will be distributed.

U.S. DOC, the Pan American Health Organization, the Chilean Ministry of
Health, the Santiago Chamber of Commerce, and the GHTF Steering Planning
Committee are now focusing on planning the May 2006 Latin America
regulatory seminar. Jeffrey Gren completed an advance trip to Santiago,
Chile July 28 and 29, 2005.

U.S. DOC is planning to apply for 2006 APEC funding for an additional
medical device regulatory training event to take place during 2007. U.S.
DOC will coordinate the details of the training program for which it
will apply in cooperation with industry, the GHTF Steering Committee,
and APEC economies.

I. *Conclusion:* The APEC Asia regulatory training program was viewed as
an overwhelming success. A significant number of regulators and industry
representatives from APEC economies with developing regulatory systems
attended and were very satisfied with the program based on evaluation
forms. The trainers also did an excellent job and the slides developed
and the video of the seminar will serve as a future reference for
regulators. The video and slides will also be made available to
regulators from APEC economies that did not attend the seminar.

The key to continued success is the involvement of APEC regulators and
industry representatives in the Asian Harmonization Working Party and
the Global Harmonization Task Force.

U.S. DOC, AHWP, and GHTF wish to thank APEC for providing this funding,
which will have a positive impact on the global harmonization of medical
device regulations, auditing procedures, and safety vigilance.

**MEDICAL DEVICES: Move to set world health standards**

**Published on Jun 15, 2005**

Thailand backs bid for more consumer protection as states meet in
Bangkok\
\
Thailand and Apec member-states are looking to introduce a single world
standard to regulate medical devices.\
\
The move aims to better protect consumers in the face of rapid
technological advancement.\
\
About 200 representatives from Apec countries are meeting in Bangkok
this week.\
\
Their main focus is how to implement one world-standard for medical
devices.\
\
The instruments have mainly been developed in five countries leading the
world in advanced medical technology.\
\
The Global Harmonisation Task Force (GHTF) is made up of the United
States, the European Union, Canada, Japan and Australia, said Pakdee
Pothisiri, of Thailand's Food and Drug Administration.\
\
Pakdee said Thailand has to adopt more sophisticated regulations,
including efficiency auditing, quality control and safety surveillance.\
\
The country's classification system for medical devices had to be
upgraded, for instance, from its three current levels\
\
-- which gauge the degree of risk any device poses to the lives of
patients -- to four categories, so they match world standards, he said.\
\
Thailand currently groups medical devices as high, medium and low risk.\
\
Products advertised on direct-sale television programmes -- seen a lot
on local screens at present -- include a facial massage engine. These
were an example of how Thai regulatory controls on medical devices were
being flouted, he said.\
\
Most of the products' makers were guilty of false advertising, he said.\
\
"Maybe they think they can just claim their products can do anything."\
\
Meanwhile, the standards of condoms and surgical gloves have raised
concerns among medical regulators from time to time, said Pakdee.\
\
A number of random and regular tests on the quality of the two products
have revealed that some producers sometimes fail to meet minimum
standards set down by the authorities, he said, adding companies had
been warned and assisted in maintaining their standards as a
consequence.\
\
"Every year we export a gigantic number of condoms to the world, that's
the reason we have to be extremely strict when it comes to product
controls," he said. The meeting began on Monday and ends on Friday.\
\
Arthit Khwankhom The Nation

[^1]: Includes \$4,000 for video recording and production of video CDs.
    The U.S. Government and industry will share costs for video CDs.

[^2]: Includes audiovisual equipment for presentations.