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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 …

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. …

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 …

National competent authorities (human) | European …

    https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human
    Croatia: Agency for medicinal products and medical devices of Croatia: …

Croatia Medical Device Registration - HALMED Approval

    https://arazygroup.com/medical-device-registration-croatia/
    In Croatia, medical devices are regulated by HALMED, the Croatian Agency for Medicinal Products and Medical Devices. CLASSIFICATION: Classification …

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 …

Cooperation between HALMED and GMP …

    https://www.ema.europa.eu/en/documents/presentation/presentation-cooperation-between-croatian-agency-medicinal-products-medical-devices-good_en.pdf
    AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES OF CROATIA - HALMED Independent institution with public authority Medicinal products for human use …

Our Guide to Registering Medical Devices …

    https://www.regdesk.co/our-guide-registering-medical-devices-croatia/
    Our Guide to Registering Medical Devices in Croatia. Mar 6, 2019. In Croatia, the governmental body responsible for regulating medical devices is the Agency …

HALMED - Agency for medicinal products and medical devices

    https://www.developmentaid.org/donors/view/65677/halmed-agency-for-medicinal-products-and-medical-devices
    Description. The Agency for Medicinal Products and Medical Devices is a legal entity vested with public authority. It was established on 1st October 2003 as a legal successor …



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