WHO is an official observer to the International Medical Device Regulators Forum (IMDRF). The IMDRF is established to address the common public health regulatory challenges to convergence due to the globalization of medical device production and the emergence of new technologies. The IMDRF recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. The Medical Device Single Audit Program (MDSAP) allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. The WHO Prequalification is an official observer to the MDSAP and as such can benefit from MDSAP reports to support its decision-making.
Prequalification procedures allow WHO to implement an inspection of manufacturing site(s) based on a desk review of information on an inspection of the manufacturing site(s) conducted in accordance with the terms of the Medical Devices Single Audit Program (MDSAP). Based on a successful integration of MDSAP reports into prequalification inspections and as part of a broader effort to enhance reliance and recognition as key regulatory principles applied for prequalification assessments of IVDs WHO has taken the executive decision to rely on MDSAP reports to perform a desk review in lieu of a WHO on-site inspection. Documentary evidence of compliance with prequalification requirements may be requested by WHO as indicated in the relevant prequalification procedures. This measure will enter into force as of 01 May 2024.