Do we need prequalification of AI as a medical device to drive equitable adoption.

Artificial intelligence offers transformative potential for global health, yet regulatory disparities threaten equitable adoption. This brief examines whether the World Health Organization's Prequalification (PQ) framework should extend to AI. We highlight limitations of applying static product paradigms to dynamic systems, outline targeted reforms, and propose a reimagined PQ4AI that balances global technical assurance with local regulatory accountability to foster safe, effective, and equitable deployments.