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Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 1 (SG1) > Directory of Study Group 1 Members |
Ginette Michaud, M.D., Chair
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Blvd., HFZ-480
Rockville
MD 20850
UNITED STATES
Tel: +1 240 276 3700
Fax: +1 240 276 3789
e-mail: ginette.michaud@fda.hhs.gov
Benny Ons, Vice-Chair
Director Regulatory Affairs 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
Mr. Alan Kent, Secretary
7 Hillsborough Park
Camberley, Surrey
GU15 1HG
UNITED KINGDOM
Tel: +44 1276 24889
e-mail: alan.w.kent@ntlworld.com
Australia:
Regulatory authority
Michael Flood
Therapeutic Goods Administration
Program Manager
Device Registration and Assessment Section
PO Box 100
Woden ACT 2606
AUSTRALIA
Tel: +61 2 6232 8615
Fax: +61 2 6232 8785
e-mail: michael.flood@health.gov.au
Industry - vacant
Japan:
Regulatory authority
Shinichi Takae
Ministry of Health, Labour and Welfare
Specialist for New Materials
Office of Medical Devices Evaluation
Evaluation and Licensing Division
Pharmaceutical and Food Safety Bureau
1-2-2, Kasumigaseki, Chiyoda-ku
Tokyo 100-8916 , JAPAN
TEL +81-3 -3595-2419
FAX +81-3 -3597-0332
E-mail: takae-shinichi@mhlw.go.jp
Industry
Naoki Morooka
JIRA
c/o Yushima KC Bldg.
18-12, Yushima 2-Chome
Bunkyo-Ku
Tokyo
113-0034 JAPAN
Tel +81 75 823 1257
Fax +81 75 823 1377
e-mail: morooka@shimadzu.co.jp
Regulatory authority
Mr. John Brennan
European Commission
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@ec.europa.eu
Mrs. Elke Lehmann
European Commission
c/o BfArM
Kurt-Georg-Kiesinger-Allee 3
D 53175 Bonn GERMANY
Tel: 49 228 2073693
Fax: 49-228-207 5300
e-mail: e.lehmann@bfarm.de
Dr. Johann Rader*
European Commission
c/o Certification, Medical Devices
TUV Product Service
Ridlerstrasse 65
Munich 80339
GERMANY
Tel: + 49 89 5008 4250
Fax: + 49 89 5008 4327
email: johann.rader@tuev-sued.de
[* = alternate]
Industry
Dr. Peter Linders
COCIR/ European Medical Device Industry Group
c/o Philips Medical Systems
P.O. Box 10000
Best 5680 DA
NETHERLANDS
Tel: +1 31 40 276 2101
Fax: +1 31 40 276 3017
e-mail: peter.linders@philips.com
Dr. Carl F. Wallroth
EUROM VI/ European Medical Device Industry Group
c/o Draeger MT
Moislinger Allee 53/55
D-23542 Luebeck
GERMANY
Tel: +49 451 882 2267
Fax: +49 451 882 4596
e-mail: beate.moeller@draeger.com
Canada
Regulatory authority
Ms. Nancy Shadeed
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
Industry
Ms. Brenda Murphy
MEDEC Canada
c/o SCICAN, 1440 Don Mills Road
Toronto
Ontario M3B 3P9
CANADA
Tel: +1 416 446 2797
e-mail: bmurphy@scican.com
United States
Regulatory authority
Mark N.Melkerson
US FDA
Director, Division of General, Restorative and Neurological Devices
CDRH/Office of Device Evaluation
9200 Corporate Blvd.,
HFZ-410, 350C
Rockville, MD 20850
UNITED STATES
Tel +1 240 276 3737
Fax +1 240 276 3602
e-mail: mark.melkerson@fda.hhs.gov
Industry
Mr. Michael Gropp
AdvaMed, USA
Vice President, Global Regulatory Strategy
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
Tel: +1-763-505-3053
Fax: + 1-763-505-2630
email: Michael.b.gropp@medtronic.com
[* = alternates]
Updated 3 April 2008
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