Medical Device Single Audit Program – International Medical Device Regulators Forum International Coalition Pilot Program

by / Friday, 27 October 2017 / Published in International Medical Device

I. Background

The  International Medical Device Regulators Forum (IMDRF) recognizes the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices.  The IMDRF, at its inaugural meeting in Singapore in 2012, identified a Work Group to develop specific documents for advancing the concept of the  Medical Device Single Audit Program (MDSAP).

This global approach opens possibilities and pathways to support the development of an international initiative of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale in a Pilot Program starting in January 2014.  For many reasons not all IMDRF member countries are able to participate in the pilot at this stage, including changes of medical device legislation, the necessity to have in place country to country confidentiality agreements, etc.  This does not diminish the support of all IMDRF member countries in the concept and, most importantly, in the development of the base documents being developed by the IMDRF MDSAP Working Group.

The international partners for the MDSAP Pilot Program starting January 2014 are the Therapeutic Goods Administration (TGA) of Australia, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the U.S. Food and Drug Administration; Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are official observers and active participants in the Pilot Program’s Regulatory Authority Council and subject matter expert groups readmore …..

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