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Med Device Technol
; 13(10): 32-3, 2002 Dec.
Artigo
em Inglês
| MEDLINE
| ID: mdl-12575528
RESUMO
In 2002 the Food and Drug Administration implemented new requirements for foreign companies that import medical devices into the United States (US). This article reviews the Establishment Registration requirements and discusses the new Establishment Registration and US Agent requirements for non-US companies.