Have there been discussions with WHO regarding the pre-clearance process for IVDs and taking account the results of an MDSAP audit?  Will medical devices assessed by the WHO be included in the program at a later stage?

WHO is participating as an observer to the MDSAP. WHO has indicated a willingness to adapt and integrate MDSAP processes as much as possible in their Prequalification Program. WHO intends to utilize MDSAP reports where possible if they are available for devices that are subject to their Prequalification Program.