RA contact details

MDSAP RAC CHAIR AND SECRETARIAT - 2024 and 2025

MDSAP.RAC.Secretariat@tga.gov.au

Medical Devices & Product Quality Division
Therapeutic Goods Administration
Australian Government, Department of Health and Aged Care
PO Box 100, Woden ACT 2606 Australia

AUSTRALIA - TGA

MDSAP@tga.gov.au

Medical Device Single Audit Program
Medical Devices Authorisations Branch
Therapeutic Goods Administration
Australian Government, Department of Health and Aged Care
PO Box 100, Woden ACT 2606 Australia

Phone: +61 1800 141 144

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

Phone: 0800 642 9782 (Portuguese only)

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

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 Compliance and Manufacturing Quality for Medical Devices

Division of Registered Certification Body Assessment
Shin-kasumigaseki Bldg. 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

Phone: 81-3-3506-9590

USA - FDA

MDSAP@fda.hhs.gov

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

Phone: 301-796-5500 (main number – ask to connect to a member of the MDSAP team)