Puerto Rico is a freely associated territory that is part of the United
States. Puerto Rican residents are United States citizens, and federal US
law fully applies on the island. All matters pertaining to medical devices
(registration, GMP compliance etc.) are the same as they are for the US
proper, and are handled by the US FDA. Medical device registration is
handled with FDA's CDRH in Maryland.
I know that PR has its own Olympic Games team (separate from the US team),
but this is a historical anachronism from the cold war.
With Best Regards,
Michael Anisfeld
Globepharm
e-mail: manisfeld@globepharm.org
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