Why FDA certification is the new moat in India's MedTech race

For Indian healthcare and Medical technology (MedTech) startups, the path to global legitimacy doesn't begin in a Bangalore lab or a Mumbai hospital; it begins 8,000 miles away, at the Maryland headquarters of the US Food and Drug Administration (FDA), the agency in charge of regulating drugs, food, biologics, and medical devices.

An FDA clearance transforms unknowns into contenders. It opens doors to American hospital systems, reassures European distributors, and turns cautious investors into believers. But the journey is punishing: two-year timelines, seven-figure costs, and regulatory mazes that have brought down even well-funded startups.