MDSAP Affiliate Membership Application Form

Overview

Please complete this digital form to apply for Affiliate Membership to the Medical Device Single Audit Program (MDSAP).

MDSAP Membership is only available to Regulatory Authorities exercising a legal legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements.

To be eligible for Affiliate Membership, an organization must meet the below criteria (Section 5.3 of MDSAP P003):

• Be a Regulatory Authority
• Demonstrate an understanding of the MDSAP and plan to utilize MDSAP audit reports and/or MDSAP certificates for evaluating compliance with applicable medical device requirements, including a manufacturer's quality management system, under the regulatory framework
• Commit to fulfill training, information, and meeting obligations 
• Commit to providing an annual report to the RAC on the utilization of MDSAP audit reports and/or MDSAP certificates
• Commit to promote MDSAP and advocate adoption and use to non-MDSAP members.

Applications will be reviewed by the Chair of the MDSAP Regulatory Authority Council Secretariat (RAC) for the broader consideration by the RAC at the next scheduled meeting.