MDSAP Official Observer Application Form

Overview

Please complete this digital form to apply for Official Observer 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 membership as an Official Observer, an organization must meet the below criteria (Section 5.3 of MDSAP P003):

• Be the World Health Organization or a Regulatory Authority
• Have been an Affiliate Member for at least the last three (3) consecutive years prior to the application for Official Observer
• If a Regulatory Authority, have current systems established for assessing a medical device manufacturer's quality management system
• Demonstrate a perceived contribution or value to the MDSAP
• If a Regulatory Authority, operate a mature or maturing system for medical device regulation which should include:
  • Established laws and regulations for medical devices building substantially on intentionally harmonized principles such as those of GHTF and IMDRF
  • Proper competencies for effective implementation and enforcement of the established laws and regulation
  • A system for conformity assessment of devices building on internationally harmonized guidance documents such as those of GHTF and IMDRF
  • Sufficient resources and regulatory expertise to perform its duties.
• Agree to confidentiality requirements - entities granted an Official Observers status after November 1, 2022: Official Observers must have a Confidentiality Agreement with all regulatory authorities that are members of the RAC
• Demonstrate capacity to contribute resources and expertise to the objectives of the MDSAP by participation in the MDSAP forums for the last three (3) consecutive years
• Provide a recognized commitment to the objectives of the MDSAP demonstrated by use of the MDSAP within regulatory framework
• Commit to fulfill training, information, and meeting obligations 
• Commit to providing an update on the utilization of the MDSAP at annual MDSAP Forums.

¹ Regarding the European Union: Individuals from Member States may participate and serve as representatives of the European Union without their own confidentiality agreements with the members of the RAC.  

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.