The Approach of MDSAP and Its Current Situation

Abstract

The Medical Device Single Audit Program (MDSAP) is a framework wherein third-party auditing organizations, deemed appropriate by MDSAP participating countries, conduct Quality Management System (QMS) audits on medical device manufacturers, with the results being utilized by each respective country. Rooted in a framework discussed in the arena of international regulatory harmonization, the MDSAP, under the leadership of Japan, the United States, Canada, Australia, and Brazil, has been implemented in society since 2017, following pilot demonstrations. However, its approach differs from the international regulatory harmonization framework for pharmaceuticals, which are also medical products, and can be difficult to comprehend for those unfamiliar with international regulations concerning medical devices. Therefore, this paper aims to clarify the characteristics of the MDSAP by contrasting its efforts with the case in the pharmaceutical field. Moreover, this paper revisits the history of the MDSAP, from its inception to its current state, while simultaneously providing an overview of the MDSAP.