In vitro Diagnostic Medical Devices pp 27-58 | Cite as
Law and Practice in the Federal Republic of Germany
Chapter
Abstract
In the Federal Republic of Germany, IVDMDs are not subject to regulation by a single specific statute or regulation. Rather, various statutes and regulations are specifically applicable to IVDMDs. These statutes and regulations are administered by different Federal and State administrative authorities.
Keywords
Federal Republic Test Antigen Competent Authority Marketing Authorization Device Safety
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© Springer Science+Business Media Dordrecht 1994