The USFDA Myth: Does Your Hospital in Nepal Really Need That $50,000 Label? Hi everyone, I’m Prabhakar , a Biomedical Engineer working on the frontlines of Nepal’s healthcare technology. From busy labs in Kathmandu to remote district hospitals, I’ve installed and maintained everything from biochemistry analyzers to advanced imaging systems. Over the years, I’ve noticed a recurring trend: the “USFDA obsession.” Whenever a hospital board or private lab plans to purchase new equipment, the first question is almost always: “Is it USFDA approved?” In Nepal, this label has become shorthand for “the best.” But as someone who repairs these machines when they fail, I can confidently say: the label doesn’t always tell the full story. 1. What Is USFDA Approval—Really? The U.S. Food and Drug Administration (USFDA) regulates medical devices specifically for the United States market . Here’s what that actually means: It’s a market authorization, not a global ranking. It confir...
Biomedical Engineer