MDSAP Regulatory Authority Council (RAC) Member Application Form

Overview

Please complete this digital form to apply for MDSAP Regulatory Authority Council (RAC)  Membership to the Medical Device Single Audit Program.

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 membership as an MDSAP RAC Member, an organization must meet the below criteria (Section 5.3 of MDSAP P003):

• Be a Regulatory Authority
• Have been an Official Observer for at least the last two (2) consecutive years prior to the application for membership
• Have participated in all MDSAP meetings designated as "OPEN to RAC Members, Official Observers, and Affiliate Members" for the last two (2) consecutive years
• Have sufficient capacity to Chair the RAC and provide the Secretariat for a period of two years (with all MDSAP communications being in English);
• Have a Confidentiality Agreement with all Regularity Authorities that are members of the RAC
• Have sufficient capacity, resources, and competencies to carry out RAC responsibilities including participating and leading assessments of Auditing Organizations (see also IMDRF MDSAP N6). A RAC Member should be able to devote at least 2 full time employees and associated travel expenses to support MDSAP assessments
• Commit to the objectives of MDSAP demonstrated by use of MDSAP within their regulatory framework without need for changes to the MDSAP audit approach
• Commit to providing an update on the utilization of MDSAP at annual MDSAP Forums.

Applications will be reviewed by the Chair of the MDSAP RAC Secretariat for the broader consideration by the RAC at the next scheduled meeting.