Regulatory Affairs • Global Registration

Global Device Registration - Country List Maintenance

Published • • 16 min read

Converting the MDD standard list and Essential Requirement Checklist to General Safety and Performance Requirements showed that 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.

Converting the MDD-era standard list and Essential Requirement Checklist into the GSPR format meant reconciling the country registration list against current certificates at the same time, not treating either as a one-time compilation.

Conversion work still needs reconciliation

Converting a checklist format from MDD to GSPR is a documentation exercise. The country list sitting behind it still has to be reconciled against source certificates on the same cadence, or the conversion inherits a list that was already stale.

Completing the update required:
  • Cross-checking each country's registration status and certificate data against the source registry/salesforce record
  • Correcting discrepancies found during the conversion
  • Updating the master tracker with the required countries

What a stale entry risks

A country's registration status going stale in the tracker, a certificate expired or a requirement changed, without anyone noticing until a shipment is blocked is the same risk whether the checklist behind it is MDD or GSPR format.

What the update delivered

Updating the global device registration list, adding the required countries and reconciling it against current certificates, kept the list current alongside the MDD-to-GSPR conversion.

The Real Takeaway

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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