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Consultation closed

Standalone Software: Key Definitions

Start date

Friday, 30 August 2013

Closing date

Friday, 30 August 2013

Working group

Software as a Medical Device (SaMD)

Member sites

Therapeutic Goods Administration

Brazilian Health Regulatory Agency (ANVISA)

National Medical Products Administration

European Commission - Directorate-General for Health and Food Safety

Pharmaceutical and Medical Devices Agency (PMDA)

Russian Ministry of Health

Health Sciences Authority

Ministry of Food and Drug Safety

Medicines and Healthcare products Regulatory Agency

US Food and Drug Administration

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

World Health Organization (WHO)

Affiliate members

SAHPRA - South African Health Products Regulatory Authority