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  4. Medical Device Single Audit Program (MDSAP)
  5. MDSAP Regulatory Authority Contact Information
  1. Medical Device Single Audit Program (MDSAP)

MDSAP Regulatory Authority Contact Information

AUSTRALIA - TGA

MDSAP@tga.gov.au

Medical Device Single Audit Program (MDSAP)
Medical Devices Branch (MDB)
Therapeutic Goods Administration (TGA)
Department of Health
PO Box 100, Woden, ACT 2606 Australia

BRAZIL - ANVISA

MDSAP.ATENDIMENTO@ANVISA.GOV.BR

Anvisa - Agência Nacional de Vigilância Sanitária
Setor de Indústria e Abastecimento (SIA) - Trecho 5, Área Especial 57 / Lote 200
Brasília (DF) - Brazil
POSTAL CODE: 71205-050

CANADA - HC

qs.mdb@hc-sc.gc.ca

Quality Systems Section
Medical Devices Directorate
5th floor - Holland Cross, Tower A
11 Holland Avenue
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9

JAPAN - PMDA

MDSAP@pmda.go.jp

Japan's Ministry of Health, Labour and Welfare
Ministry of Health, Labour and Welfare
Medical Device Evaluation Division,
Pharmaceutical Safety and Environmental Health Bureau
1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 1008616 Japan

Pharmaceuticals and Medical Devices Agency
Office of Manufacturing/Quality and Compliance - Division of Registered Certification Body Assessment
Shin-kasumigaseki Bldg. 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

US - FDA

MDSAP@FDA.HHS.GOV

US FDA - Food and Drug Administration
Center for Devices and Radiological Health
Office of Product Evaluation and Quality/Office of Regulatory Programs
10903 New Hampshire Avenue
Building 66 Room 1457
Silver Spring, MD 20993-0002
Tel.: 301-796-5500 (main number)

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