Issuance of free-sale certificates

The free sale certificate is issued for export purposes to manufacturers of medical devices or in vitro diagnostic medical devices, as the case may be, or to authorised representatives based in Romania, in line with Art. 60 of the MDR/ Art. 55 of the IVDR, Art. 6 of Emergency Government Ordinance no. 46/2021/ Art. 4 of Emergency Government Ordinance no. 137/2022 and with the provisions of Order of the Minister of Health no. 1171/2022.

For the issuance of free-sale certificates for medical devices, respectively for medical devices for in vitro diagnosis, the applicant submits to the NAMMDR the application for issuance of a free-sale certificate for medical devices, respectively for in vitro diagnostic medical devices, filled in with the data requested therein, together with the documents specified therein, as appropriate.

You can download the application for the issuance of a free-sale certificate for medical devices and the Form for payment of the fee – FREE-SALE CERTIFICATE from the Medical Devices/Forms and fees webpage.

https://www.anm.ro/dispozitive-medicale/formulare-si-tarife/

In line with the provisions of Art.2 paragraph (2) of Order no. 3467 of 17 November 2022: “(2) The fees provided for in Annex 1 shall be paid prior to the registration of requests for provision of the requested services, unless otherwise provided by the regulatory acts regulating them.”

After filling in the fee payment form, it shall be submitted electronically to registratura@anm.ro or physically at the NAMMDR headquarters in 48 Aviator Maior Ștefan Sănătescu street, Sector 1, 011478, Bucharest, and the respective request shall be invoiced by the NAMMDR.

After paying and confirming it, you may register your request by sending an e-mail to drsp@anm.ro or at the NAMMDR headquarters in 48 Aviator Maior Ștefan Sănătescu street, Sector 1, 011478, Bucharest.