Official Observer

Except for the WHO, an MDSAP Official Observer is a RA which contributes to RAC activities or observes the operations of the program without being a formal member.  Current MDSAP Official Observers can be found here.

Official Observers utilize MDSAP audit reports and MDSAP certificates for evaluating compliance with applicable medical device requirements, including a manufacturer's QMS, under the Official Observer's regulatory framework. Official Observers have access to reporting information in the MDSAP IT Portal.

Upon satisfactory completion of MDSAP Assessor competence and training requirements, Official Observers may:  

• participate as observers in MDSAP assessment activities, including on-site assessments of AOs and witnessed audits of manufacturers 
• act as an MDSAP Assessor for on-site assessments of AOs. MDSAP Official Observers provide at least one (1) MDSAP Assessor to participate in in-country or regional MDSAP assessments. 

Full information on Official Observer requirements is available at MDSAP Roles and Responsibilities.