Establish a Global Medical Device Recognition framework with two tiers: (1) Tier 1 (Mutual Recognition): FDA, EMA, PMDA, and Canada's Health Canada establish mutual recognition of each other's pre-market approvals — device approved by any one Tier 1 regulator is automatically approved in all others within 90 days, pending real-time safety monitoring integration.

This solves the approval delays for wealthy markets immediately. (2) Tier 2 (Accelerated Access): Developing countries and emerging markets join a tiered system: devices approved by Tier 1 regulators can enter Tier 2 markets with an abbreviated local review (30 days, focused on post-market surveillance capability rather than re-proving safety).

WHO provides technical assistance to Tier 2 regulators to build capacity. Phase in over 5 years, starting with cardiovascular and oncology devices where delays have highest clinical impact.

Create a real-time global adverse event database shared across all participating regulators — eliminating the current information siloes that prevent regulators from learning from each other's post-market experience.