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Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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| GHTF > Study Groups > Study Group 1 (SG1) > Directory of Study Group 1 Members |
Nancy Shadeed, Chairwoman
Health Canada
Medical Devices Bureau
Room 1605, Main Statistics Building
Tunney's Pasture, PL# 0301H1
Ottawa , Ontario, K1A 0L2, CANADA
Tel: +1 613 957 7090 Fax: +1 613 957 7318
e-mail: nancy_shadeed@hc-sc.gc.ca
Benny Ons, Vice-Chairman
BD Biosciences
Director Regulatory Affairs and Quality Management
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
Regulatory authority
Gary Burgess
Therapeutic Goods Administration
Director, Medical Device Application Section
Office of Devices, Blood and Tissues
PO Box 100
WODEN ACT 2606
AUSTRALIA
Tel: +61 2 6232 8514
Fax: +61 2 6232 8785
Email: gary.burgess@tga.gov.au
Industry
Cliff Spong
Medical Technology Association of Austratia (MTAA)
Canberra Office
Director of Regulatory and Scientific Affairs
Medical Technology Association of Australia
Suite 10, Serron CyberCentre,
12 Albany St, Fyshwick ACT 2609 AUSTRALIA
Tel: + 61 (0) 2 6260 4570
+ 61 (0) 427 013 084
Fax: +61 (0) 2 6260 4590
Email: cspong@mtaa.org.au
Regulatory authority
Atsushi Tamura
Pharmaceuticals and Medical Devices Agency (PMDA)
Coordination Director
Office of Medical Devices
Shin-Kasumigaseki Bldg
3-3-2, Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 JAPAN
Tel: +81-3-3506-9447
Fax: +81-3-3506-9466
email: tamura-atsushi@pmda.go.jp
Mr. Kentaro Azuma
Ministry of Health, Labour and Welfare
New Medical Material Specialist
Office of Medical Devices Evaluation
Pharmaceutical and Food Safety Bureau
1-2-2 Kasumigaseki
Chiyoda-ku, Tokyo 100-8916, JAPAN
Tel: +81 3 5253 1111 ext. 2787
Fax: +81 3 3597 0332
e-mail: azuma-kentaro@mhlw.go.jp
Industry
Naoki Morooka
The Japan Federation of Medical Device Associations (JFMDA)
c/o Shimadzu Corporation
1, Nishinokyo-Kuwabaracho
Nakagyo-ku, Kyoto 604-8511, JAPAN
Tel +81 75 823 1257
Fax +81 75 823 1377
e-mail: morooka@shimadzu.co.jp
Tomomichi Nakazaki
The Japan Federation of Medical Device Associations (JFMDA)
Iidabashi Square Bldg, 3-2
Shimomiyabi-cho, Shinjuku-ku
Tokyo 162-0822 JAPAN
Tel: +81-3-5225-6234
Fax: +81-3-3260-9092
email: t-nakazaki@basil.ocn.ne.jp
Regulatory authority
Peter Bischoff-Everding
European Commission
DG Enterprise and Industry
Unit F-3 “Cosmetics & Medical Devices”
Av. d'Auderghem 45, B-1040 Brussels, BELGIUM
Tel: + 32-2-29.85278
Fax: +32-2-29.66467
e-mail: peter.bischoff-everding@ec.europa.eu
Dr. Lennart Philipson
Director Medical Devices
Medical Products Agency
P.O. Box 26
SE-751 03 Uppsala
SWEDEN
Tel: +46 18 172652
Fax: +46 18 503115
e-mail: lennart.philipson@mpa.se
Industry
Dr. Peter Linders
COCIR/ European Medical Device Industry Group
c/o Philips Healthcare
P.O. Box 10000, Best 5680 DA, NETHERLANDS
Tel: +31 40 276 2490
Fax: +31 40 276 2651
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
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: +1 613 957 7090
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 Food and Drug Administration
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
Michael C. Morton
AdvaMed, USA
Senior Director Global Regulatory Affairs
Medtronic, Inc.
710 Medtronic Parkway, LC270
Minneapolis, MN 55432, USA
Tel: +1 763.505.2997
+ 1 612.280.8812
Fax: + 1 763.505.2013
email: michael.morton@medtronic.com
Regulatory Authorities:
Huifen Bai
Regulatory Specialist
Health Sciences Authority
Evaluation Unit
Medical Device Branch
Therapeutic Products Division
Health Products Regulation Group
11 Biopolis Way, #11-01, Helios,
SINGAPORE 138667
Tel: + (65) 6866 3572
Fax: + (65) 6478 9028
email: : bai_huifen@hsa.gov.sg
Eng. Mesha’l Alamri
Saudi Food and Drug Authority
Director, Conformity Assessment Department
Medical Devices Sector
3292 Northen Ring Road - Al Nafel Area - Riyadh 13312 -6288]
SAUDI ARABIA
Tel: (+966) (1) 2759222 ext. 2424
Fax: (+966) (1) 2757245
e-mail: maamri@sfda.gov.sa
Industry:
Ms. Daphne Yeh
Phillips Medical System
Director, Quality and Regulatory, Asia Pacific
15F No. 3-1 Yuan Qu Street, NanGang District
Taipei 115, CHINESE TAIPAI
Tel: + 886 2 3789 2662
Fax: +886-2-3789-2906
email: Daphne.yeh@philips.com
Dr. Lindsay Tao
Johnson & Johnson
Corporate Director
Regulatory Government Affairs, Asia Pacific
4th F, Chengkai International Center
355 Hong Qiao Rd,
Shanghai, CHINA 200030
Tel: + 86-21-22058288(phone)
Fax: * 86-21-22059262
email: LTAO@its.jnj.com
Updated 2 July 2010
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