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.

Context

Transferring data for 4 light stands, 3 Healix-type bone fixation devices, and 2 VAPR products into the country list meant reconciling each against current certificates rather than treating the list as a one-time compilation.

Global Registration Regulatory Affairs

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 the required countries 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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