Medical device registration on market placement

On market placement of the following types of medical devices, NAMMD registration of manufacturers or their authorised representatives established in Romania is mandatory:
(a) Class I medical devices, including sterile and / or measuring devices;
(b) Custom-made medical devices and custom-made active implantable medical devices;
(c) Systems and procedure packages referred to in Article 29 of Government Decision no. 54/2009;
(d) In-vitro diagnostic medical devices.

Form F1
download document …
download document …
Form F2
download document …
download document …

Notification of medical devices on putting into service

(1) NAMMD notification by manufacturers, their authorised representative, importers or distributors established in Romania/other Member State on putting into service in Romania of the following types of medical devices is mandatory:
(a) Classes IIa, IIb and III medical devices;
(b) In-vitro diagnostic medical devices covered by Annex no. 2 to Government Decision no. 798/2003;
(c) In-vitro diagnostic medical devices for self-testing;
(d) active implantable medical devices.

Form F3
download document …
download document …

Notifications shall be submitted within 3 months of the medical device putting into service.

IMPORTANT NOTICE
Record into the national data base of medical devices placed on the market / put into operation in Romania does not mean approval or authorisation by the NAMMD, the medical devices competent authority.

Record of medical devices into the national data base is free of charge.