Medical Device Registration Romania

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Registration of medical devices into the national database – …

https://www.anm.ro/en/dispozitive-medicale/inregistrare-dispozitive-medicale-in-baza-nationala-de-date/

On market placement of the following types of medical devices, NAMMD registration of manufacturers or their authorised representatives established in Romania is mandatory: …

National Agency for Medicines and Medical …

https://www.anm.ro/en/

Registration of medical devices into the national database; Grant of customs notice; Grant of donation notice; Issuance of an out-of-scope notice; Vigilance; Market surveillance; …

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 …

Medical Device Registration in Romania - omcmedical.com

https://omcmedical.com/medical-device-registration-in-romania/

Registration Process: Determine the device classification. Appoint an Authorized Representative and Notified Body. The medical devices must be registered in the …

Healthcare Resource Guide - Romania - International …

https://www.trade.gov/healthcare-resource-guide-romania

Healthcare in Romania is dominated by the public sector, which owns most of the hospitals and provides national health insurance to almost all Romanian citizens. Healthcare …

Romania changes registration requirements for medical devices …

https://www.cms-lawnow.com/ealerts/2020/04/romania-changes-registration-requirements-for-medical-devices-during-state-of-emergency?cc_lang=en

Romania changes registration requirements for medical devices during state of emergency. On 31 March 2020, the Romanian Ministry of Health issued Order …

Healthcare Resource Guide: Romania - Export.gov - Home

https://2016.export.gov/industry/health/healthcareresourceguide/eg_main_108613.asp

Registration Process There are no restrictions on the sales and imports of new and refurbished medical devices in Romania. The medical equipment must meet the …

Romania – Medical Device Registration …

https://regulamedica.com/product/romania-medical-device-registration/

Romania – Medical Device Registration Guideline € 289,00 Add to cart Regulamedica Guidelines are provided in English language only, however per your request we …

Medical Device Consulting for Bucharest, Romania - MEDIcept

http://www.medicept.com/medical-device-consulting-for/Bucharest/Romania/

As a medical regulatory and compliance consulting firm specializing in FDA medical device consulting, MEDIcept is uniquely positioned to act as a US agent and assist European …

Which Countries Require CE Marking of …

https://medicaldeviceacademy.com/which-countries-require-ce-marking-of-medical-devices/

The next step is to select an Authorized Representative in the KSA and submit a Medical Device Marketing Authorization (MDMA) application. For low and …

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