Affiliate Member

Affiliate Members are RAs that engage in MDSAP, demonstrate understanding of MDSAP and utilize MDSAP audit reports and MDSAP certificates for evaluating compliance with applicable medical device requirements, including a manufacturer's QMS, under the Affiliate Member's regulatory framework.  Current Affiliate Members can be found here.

Affiliate Members report annually on the utilization of MDSAP audit reports and/or MDSAP certificates to the RAC. Affiliate Members do not have access to the MDSAP IT Portal. Instead, Affiliate Members have access to a list of participating MDSAP facilities, which contains information on the manufacturer, manufacturing site, audit dates and the responsible AO. Affiliate Members can obtain MDSAP audit reports and/or MDSAP certificates by contacting participating manufacturers.

Full information on Affiliate membership is available at MDSAP Roles and Responsibilities.