Context
Updating the master SKU list required reconciling Taiwan FDA UDI requirements, Central Asia, and EMA data against the current global device registration list, rather than treating the list as a static compilation.
Regulatory Affairs • Global Registration
Global Device Registration - Country List Maintenance
Duration: 2 months • Role: Regulatory Affairs Specialist
A global registration country list is a moving target, it has to be reconciled against source certificates and government registries on a cadence, not treated as a one-time compilation.
Primary Risks Identified
- A country's registration status going stale in the tracker (e.g. certificate expired or requirement changed) without anyone noticing until a shipment is blocked
Testing Approach
Cross-checked each country's registration status and certificate data against the source registry/salesforce record, corrected discrepancies, and updated the master tracker.
Registry Cross-Check
Certificate Verification
Master Tracker Update
Outcome
Updated the global device registration list, adding Taiwan, Central Asia, and EMA, and reconciling it against current certificates.
Key Lessons
A global registration country list is a moving target, it has to be reconciled against source certificates and government registries on a cadence, not treated as a one-time compilation.
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