The Regulated Product Submission (RPS) proposal was endorsed as a New Work Item (NWI) by IMDRF at its inaugural meeting in Singapore (March 2012). The proposal, as endorsed, included the objective of establishing a comprehensive harmonized structure for regulated medical device submissions.
The submission content in this document is primarily organized to accommodate a submission package structured with nested folders. The best method to accommodate this type of nested folder structure is to prioritize where to place and find documents/information within multiple levels of folders. As a result, the order of content in this document is not intended to convey or describe the order in which content would be assembled or reviewed. Instead, content is organized by type, which may in places follow the order of submission assembly or review. The primary Chapters are few in number to facilitate easier navigation.
This document provides an internationally harmonized, modular, structure for use when filing medical device submissions to regulatory authorities for marketing. This document is comprehensive in scope in that it defines the location of both common (IMDRF) and regional content for all submission types. As a consequence, not all headings are required for all submission types and/or IMDRF jurisdictions.
Revisions to this document since its initial release reflect input from the public and experience gained from use of the initial version.