1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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LEADERSHIP
Ms. Nancy Shadeed, Chair
Health Canada
Medical Devices Bureau
Room 1605, Main Statistics Building
Tunney's Pasture, PL# 0301H1
Ottawa , Ontario
K1A 0L2
CANADA
Tel: +1 613 954 0285
Fax: +1 613 957 7318
e-mail: nancy_shadeed@hc-sc.gc.ca
ASIA-PACIFIC
Australia
Regulatory authority
Shelley Tang
Head, Medical Devices Assessment Section
Office of Devices, Blood and Tissues
T herapeutic Goods Administration (TGA)
136 Narrabundah Lane
Symonston
ACT 2609
AUSTRALIA
Tel: +61 26232 8793
Fax +61 2 6232 8785
e-mail: Shelley.Tang@health.gov.au
Industry
Jillianne Coles (Keller)
Regulatory Affairs Manager
Panbio Ltd
532 Seventeen Mile Rocks Rd
Sinnamon Park , QLD
AUSTRALIA , 4073
Fax +61-7-3363-7199
Tel +61-7-3363-7121
e-mail: jillianne_keller@panbio.com
Sandra Russell
Manager, Diagnostics Industry
Medical Technology Association of Australia
Canberra Office Level 1, 16 Napier Close
DEAKIN ACT 2600
Tel: +612 6260 5332
Fax: +612 6260 4590
Mob: +61 0423 911 819
email: srussell@mtaa.org.au
Japan
Regulatory authority
Dr. Masaki Sugiura
Principal Reviewer, Office of Medical Devices,
Pharmaceuticals and Medical Devices Agency (PMDA)
3-3-2, Kasumigaseki, Chiyoda-ku,
Tokyo 100-0013 Japan
Tel : +81-3-3506-9447
Fax : +81-3506-9466 e-mail :
e-mail : sugiura-masaki@pmda.go.jp
Industry
Mr. Hirofumi Koide
Managing Director
Japan Association of Clinical Reagents Industries ( JACRI )
1-1, Nihonbashi-nakasu, Chuo-ku, Tokyo 103-0008 Japan
Tel : +81-3-3669-9101
Fax : +81-3-3669-6560
e-mail : hirofumi.koide@jacr.or.jp
Mr. Kazutoshi Yamagishi
Working Member, Regulatory Affairs Working Group
In Vitro Diagnostic Clinical Instrument Committee
Japan Analytical Instruments Manufacturers' Association ( JAIMA) 3
c/o Toshiba Medical Systems Corporation
Chief Specialist, Development & Engineering Group
Clinical Laboratory Systems Division
Tel: +81-287-26-6202
Fax: +81-287-26-6054
e-mail: kazutoshi.yamagishi@toshiba.co.jp
EUROPE
Regulatory authority
European Commission
Mr. John Brennan
DG Enterprise
Directorate G - Single Market: regulatory environment, standardisation
& new approach,Principal Administrator, Medical Devices Sector
SC15 3/122, Rue de la Science 15, 1040 Brussels, BELGIUM
Tel : +32-2-298.50.24
fax : +32-2-296.70.13
e-mail : john.brennan@cec.eu.int
Marie-Lise Migueres
AFSSAPS/DEDIM
Adjointe au Directeur en charge des Affaires Européennes et Internationales
143-147 Boulevard Anatole France
93285 Saint-Denis cedex
France
Tel : 00 33 1 55 87 36 85
Fax : 00 33 1 55 87 37 42
e-mail : Marie-Lise.MIGUERES@afssaps.sante.fr
Industry
Benny Ons
Director, Regulatory Compliance and Quality Management
BD Biosciences
POB 13, Denderstraat 24
B-9320 Erembodegem
BELGIUM
Tel +32 53 72 04 02
Fax +32 53 72 04 50
e-mail: Benny_ONS@europe.bd.com
Dr. Michael Thein
Head of QM & Reg. Affairs Roche Centralized Diagnostics
Roche Diagnostics GmbH
LQ, Building 161
D-68305 Mannheim
Tel. +496217598436
Fax +496217596327
Mobile +491733485573
e-mail: michael.thein@roche.com
Dr. Petra Kaars-Wiele
Director Regulatory Affairs/Affiliate Compliance
Abbott GmbH & Co.KG, Germany
EDMA Representative
Tel: +49 6122 581239
Fax +49 6122 582828
e-mail: petra.kaars-wiele@abbott.com
NORTH AMERICA
Canada
Regulatory authority
Maria Carballo
Head, IVDD Section
Device Evaluation Division
Medical Devices Bureau/TPD/Health Canada
Main Statistics Canada Bldg., Rm 1605
Tunney's Pasture, A/L 0301H1
Ottawa , ON K1A 0K9
Canada
Tel: 613-954-9391
e-mail: maria_carballo@hc-sc.gc.ca
Industry - vacant
United States
Regulatory authority
Sousan S. Altaie, Ph.D.
Scientific Policy Advisor
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Device Evaluation and Radiological Health
Food and Drug Administration, HFZ-440
2098 Gaither Road
Rockville , MD 20850
Tel: +1-240-276-0450, ext. 106
Fax: +1-240-276-0643
e-mail: Sousan.Altaie@fda.hhs.gov
Industry
Andrea J. Casper
Vice President, Worldwide Regulatory Affairs
Ortho-Clinical Diagnostics, Inc.
Representative from US Industry,
AdvaMed, Advance Medical Technology Association
1001 US Highway 202
Raritan , NJ 08876 USA
Tel: +1-908-218-8177
Fax: +1-908-218-8178
e-mail: acasper1@ocdus.jnj.com
Regina J. O'Meara*
Director, Global Legislative & Government Affairs Beckman Coulter, Inc
Brea , CA 92822 USA
Telephone: +1 -714 993 8383
Fax: +1-714 961 4234
e-mail: rjomeara@beckman.com
[* = Alternate]
Updated 3 April 2008
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