Medical device single audit program (MDSAP)

Working Group Chair(s)
Kimberly Trautman
Food and Drug Administration (FDA)
United States of America
Membership
Regulator membership
Status
Work completed

The Medical Device Single Audit Program (MDSAP) Work Group has completed its work and has moved to the implementation phase. For current information on implementation see MDSAP

The Working Group will develop a standard set of requirements for auditing organizations performing regulatory audits of medical device manufacturers' quality management systems. The document will be applicable to competent authority auditing groups/inspectorates, as well as third party organizations that conduct such audits. This is an initial critical step in establishing a single audit program. This action will complement the current ISO13485 revision process under which IMDRF seeks modifications to achieve a harmonized standard amongst its members.

Medical Device Single Audit Program (MDSAP) Working Group

MDSAP - Guidance on Regulatory Authority Assessment Methods of Auditing Organization's Processes
MDSAP - Medical Device Regulatory Audit Reports
MDSAP Assessment Outcomes and Recognition/Re-recognition Decision by Regulatory Authorities
Assessor competency and training requirements for Regulatory Authorities undertaking assessments of auditing organizations
Regulatory Assessment Program and Assessment Strategy utilizing for the recognition and monitoring of medical device auditing organizations
Recognition and monitoring of organizations undertaking audits of medical device manufacturers
Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers
Recognition Criteria for Medical Device Auditing Organizations

Participants

Keith M Smith
Therapeutic Goods Administration (TGA)

Alba Maria Campos Pismel
Brazilian Health Regulatory Agency (ANVISA)
Patricia Serpa
Brazilian Health Regulatory Agency (ANVISA)
Vivian Cardoso de Morais
Brazilian Health Regulatory Agency (ANVISA)

Tian Shaolei
Chinese Food and Drug Administration (CFDA)
Wang Aijun
Chinese Food and Drug Administration (CFDA)
Zhu Ning
Chinese Food and Drug Administration (CFDA)

Ali Al-Dalaan
Asian Harmonization Working Party (AHWP)
Sabine Ohse
World Health Organization (WHO)

Hideyuki Kondo
Ministry of Health, Labour and Welfare (MHLW)
Kenichi Ishibashi
Pharmaceuticals and Medical Devices Agency (PMDA)
Yoichi Onodera
Pharmaceuticals and Medical Devices Agency (PMDA)

Rob Higgins
Medicines and Healthcare products Regulatory Agency (MHRA)

Kimberly Trautman
Food and Drug Administration (FDA)

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

World Health Organization (WHO)

Swissmedic

 

Affiliate members

 

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Egypt - Egyptian Drug Authority  (EDA)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

South Africa - South African Health Products Regulatory Authority (SAHPRA)