Medical device registration on placement on the market
The manufacturer or the authorised representative of the manufacturer, based in Romania, has the obligation to register with the NAMMDR in accordance with the provisions of Article 6 of Order of the Minister of Health no. 3539 of 2022 on approval of the Methodological Rules regarding the introduction of medical devices on the market and the registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database and exemption from the procedures for assessment of compliance, when placing the following types of medical devices on the market:
a) Class I, IIa, IIb and III medical devices, including sterile and / or measuring devices;
b) Systems and procedure packages referred to in Article 22 of the Regulation;
c) custom-made active implantable medical devices
| Form F1 – Notification form for the introduction of medical devices on the market download document …  |
PLEASE NOTE:
The registration of medical devices introduced on the market/put into operation on Romanian territory into the national database does not represent an approval or an authorization from the NAMMD, the competent authority in the field of medical devices.
In line with Order of the Minister of Health no. 3467/2022, Annex 1, point 1.7. for issuance of a certificate of registration of medical devices into the national database (maximum 5 items), the following fee is charged: 1310 lei.
In line with Order of the Minister of Health no. 3467/2022, Annex 1, point 1.10., for Registration of amendment of information from the database with medical devices (maximum 5 items), the following fee is charged: 350 lei
The fee payment form – ISSUANCE OF REGISTRATION CERTIFICATE FOR MEDICAL DEVICES INTO THE NATIONAL DATABASE, REGISTRATION OF MODIFICATION OF INFORMATION FROM THE MEDICAL DEVICES DATABASE – is available on the “Forms and tariffs” webpage.
Following completion of the form for payment of the fee, it shall be submitted to the NAMMDR headquarters in 48 Aviator Maior Ștefan Sănătescu, Sector 1, 011478, Bucharest, or electronically to the following e-mail address: registratura@anm.ro, and the respective request shall be invoiced by the NAMMDR. After payment and its confirmation, you may submit your request to the NAMMDR headquarters in 58 Nicolae Titulescu, Sector 1, 011144, Bucharest.