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National Agency for Medicines and Medical Devices of …

    https://www.anm.ro/en/
    MEDICAL DEVICES. Important notifications – Medical Devices; Legislation – Medical Devices; Forms and fees – Medical Devices; European regulations on medical devices; CE marking; Definitions and classification of medical devices; Registration of medical devices …

Laws, ordinances and government decisions – Medical Devices

    https://www.anm.ro/en/dispozitive-medicale/legislatie/legi-ordonante-si-hotarari-de-guvern/
    EMERGENCY ORDINANCE No. 46 of 9 June 2021 on establishment of an institutional framework and measures for enforcement of Regulation (EU) 2017/745 of the …

Registration of medical devices into the national database – …

    https://www.anm.ro/en/dispozitive-medicale/inregistrare-dispozitive-medicale-in-baza-nationala-de-date/
    Medical device registration on market placement. On market placement of the following types of medical devices, NAMMD registration of manufacturers or their authorised …

Romania Medical Device Registration - NAMMD …

    https://arazygroup.com/medical-device-registration-romania/
    Medical Device Regulations and Classification in Romania. REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Romania, …



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