Medical device companies in Romania
Look up medical device manufacturers, authorised representatives, importers, and system producers registered worldwide.
Companies that place medical devices on the market in Romania must register in EUDAMED.
861 companies registered in Romania in EUDAMED
Medical device companies in Romania
Top locations in Romania: Bucuresti, Bucharest, Cluj-Napoca, Iasi, Brasov.
Competent authority in Romania
Medical devices placed on the market in Romania are overseen by its national competent authority for market surveillance: ANMDMR.
Frequently asked questions
Who must register in Romania?
Any manufacturer, importer, or authorised representative placing a medical device on the market in Romania must register in EUDAMED under the MDR (2017/745) or the IVDR — règlement (UE) 2017/746.
What is the competent authority for medical devices in Romania?
Each EU Member State designates a national competent authority responsible for medical device market surveillance, in line with Article 101 of the MDR (2017/745).
How many companies are registered in Romania?
861 medical device companies are currently registered in Romania in EUDAMED.