Major Global Markets

A critical analysis will be undertaken on the regulatory and legal framework of other key global regulators other than the U.S. & EU to implement necessary policies and procedures for medical device approval and market sustainability. The significance of expanding regulatory geographies will be examined, and the commonalities identified to ensure students understand the critical documents and build global regulatory files.  

The aim of this module is also to ensure that students can build a regulatory intelligence matrix to accommodate global regulatory filings, device changes and regulatory inspections, including the Medical Device Single Audit Programme 'MDSAP'.

1. Implement the regulatory requirements necessary to obtain medical device approval in all other major markets other than U.S. & Europe, including the processes required to achieve Medical Device Single Audit Process (MDSAP) application and certification.

2. Develop regulatory processes to keep devices up to date in the market with associated timelines & address device changes as appropriate. Design and validate a suitable regulatroy intelligence matrix which provides business clarity for all relevant markets.

3. Compile technical files, design dossiers, Shonin's & STED documentation in line with country specific mandates e.g. Japan - Shonin, Canada & Australia - Technical files etc.

4. Inform the business on the regulatory & postmarket expectations for the global regulatory regions to ensure adequate implementation & compliance.