Multiregional Medical Device Registration /

Abstract

The landscape of multiregional medical device registration is an area with highly variable regulations, varying regulator application and expectations, alongside swift changes in some regions. Accessing international medical device markets is a key growth strategy from a business perspective and an important component for the commercialisation of medical device portfolios. This dissertation outlines medical device registration requirements for specific regions of business growth, outside the European approval system and USA FDA clearances. Those requirements are embedded as an input into a design control process and a proposed Global Registration Dossier, to ensure delivery of all regional requirements to support regional submissions. The optimal proposed dossier will be the result of, a mapping exercise of the main regulatory submission formats that are currently used, in addition to registration benchmarking in conjunction with the literature review. The proposed Global Registration Dossier format will support a business, to deliver information that meets global registration requirements and enable timely access to this essential information. This will reduce delays in submitting devices to the appropriate regulatory agencies in the differing regions and in turn have a positive impact on the business, by means of faster approval times.