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Recent Regulatory Changes

2026​

Stage C Procurement Mandate — 23 March 2026​

Mandatory MDACS listing for all AMDs in DH public procurement. Announced December 2025. See Stage C Guide.

Revised Submission Guidance​

MDD updated procedural guidance for MDACS listing submissions, streamlining requirements for Class II devices with existing reference-country approvals.

2024–2025​

Stage B Implementation — November 2024​

Devices required to have submitted listing application (with assigned application number) for DH tender eligibility.

GN-01:2024 Published​

Updated MDACS Overview guidance note incorporating the most recent procedural changes and MDIS system updates.

Monitoring Updates​