Consensus Statement on the Future of Medical Device Registries Across Asia-Pacific & Middle East-North Africa

This document was commissioned to provide a region-specific perspective on medical device registries from medical equipment, devices and in vitro diagnostics trade associations across Asia-Pacific and Middle East-North Africa (MENA). Due to region-specific considerations and capability gaps, it is our surmise that more support from commercial stakeholders might be required than has been traditionally observed in other regions of the world. The contents included herein characterize our perspective on the role of commercial stakeholders in supporting medical registry development, implementation and maintenance that espouses:

1) Appropriate governance
2) Acquisition of appropriate qualitative/quantitative outcomes data metrics and performance measures
3) Processes that focus on data quality
4) Implementation of quality gates for data entry and registry execution/maintenance
5) Appropriate data interpretation with adjudication by multiple stakeholders

The writing committee anticipates that this statement will prove valuable to providers, payers, patients, policy makers, and other interested stakeholders.