Agency For Medicinal Products And Medical Devices Croatia

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HALMED - Agency for Medicinal Products and Medical Devices

https://www.halmed.hr/en/

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course “Distribution and good practice in medical …

Medicinal Products Database | Medicinal Products .: …

https://www.halmed.hr/en/Lijekovi/Baza-lijekova/

In the Republic of Croatia only medicinal products with marketing authorisation granted by either the Agency for Medicinal Products (HALMED) or European Commission may be …

Medical Device Registration in Croatia - Thema Med

https://www.thema-med.com/en/medical-device-registration-croatia/

All Medical Devices are subject to registration. In the case of a non-European Manufacturer, an Authorized Representative or Representative must be appointed. …

Mutual Recognition Agreement (MRA) | FDA

https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra

Jan 18, 2023

Medical Devices Database | Medical Devices .: HALMED

https://www.halmed.hr/en/Medicinski-proizvodi/Baza-medicinskih-proizvoda/

Taking into account that natural and legal persons who place medical devices and/or in vitro diagnostic medical devices on the market of the Republic of Croatia are obliged to …

Agency for Medicinal Products and Medical Devices …

https://www.fda.gov/international-programs/confidentiality-commitments/agency-medicinal-products-and-medical-devices-halmed-croatia-fda-confidentiality-commitment

The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to Agency for Medicinal Products and …

Croatia Medical Device Registration - HALMED Approval

https://arazygroup.com/medical-device-registration-croatia/

Medical Device Regulations and Classification in Croatia. REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Croatia, …

FDA - Agency for Medicinal Products and Medical …

https://www.fda.gov/international-programs/confidentiality-commitments/fda-agency-medicinal-products-and-medical-devices-halmed-croatia-confidentiality-commitment

The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) is authorized to disclose non-public information to the United States Food and Drug …

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