MDSAP: A comprehensive review of its impact, implementation, and future in global regulatory harmonisation
£40.00
Understand how MDSAP streamlines global compliance: explore its audit approach, stakeholder benefits, and key implementation challenges in this in-depth review
English
The Medical Device Single Audit Program (MDSAP) is an initiative that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple participating regulatory authorities. Fully operational since 2017, MDSAP has revolutionised the regulatory landscape for medical devices globally. The Program currently includes five participating countries: Australia, Brazil, Canada, Japan, and the USA. MDSAP aims to streamline the audit process, reduce the regulatory burden on manufacturers, and enhance regulatory oversight efficiency. This article by Pascal Bisson, with contributions from Ehab Amen, explores the history of MDSAP, identifies the various stakeholders and how they utilise the Program, and examines the benefits for both manufacturers and regulatory authorities. The article also describes the certification process and audit cycle, the audit duration, and the MDSAP audit approach, as well as highlighting common challenges manufacturers face during implementation.
Specification: 14 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2025 issue of the Journal of Medical Device Regulation.
