Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective.

Abstract

Artificial intelligence (AI) tools are rapidly reshaping ophthalmology by improving screening and diagnosis for diabetic retinopathy, age-related macular degeneration, glaucoma, and increasingly retina-based systemic risk assessment. This narrative review provides a comparative assessment of regulatory pathways governing ophthalmic AI and software as a medical device (SaMD) across the United States, European Union, United Kingdom, Australia, China, Japan, Canada, India, and selected emerging jur