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Rules - MDD Manufacturer and Product RegistrationDanish manufacturers of products which do not require certification by a notified body (devices in class I) must be registered with the Danish Medicines Agency.The same requirement applies to Danish companies that are responsible for the marketing of such products within the European Union in cases where the manufacturer's head office is situated outside the European Union. Information on the address of the head office and the categories of products that are marketed must be submitted to The Danish Medicines Agency. Back to index |
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