Thus, according to the provisions of the Order, at the date the medical devices are introduced on the market, the manufacturers are obliged to respect the following procedure for registration of these devices:
a) Filling out notification forms F.1 and F.2, depending on the type of the medical device marketed, form to be accompanied by the documents specified in it;
b) In its database, ANMDM shall register the information of the medical devices placed on the market and the information of the persons responsible for placing them on the market and shall issue to the applicant a certificate of registration of the medical devices;
c) The certificate of registration of the medical devices is issued within 30 days of receipt of the notification form filled with all data and accompanied by appropriate documentation.
In case of commissioning of medical devices in Romania, according to the provisions of the Order:
a) The manufacturer, the authorized representative of the manufacturer, the importer or distributor established in Romania or in any other Member State is obliged to notify the Ministry of Health the commissioning of medical devices in Romania, by sending the notification Form F.3 to ANMDM along with the documents mentioned in it (conformity declaration of the manufacturer’s, certified copy of the registration certificate, medical device labeling, instructions for use, certificate of conformity issued by a notified body);
b) In the database of ANMDM it shall be recorded only once a producer / product
c) ANMDM records all data allowing identification of the devices put into operation in Romania, based on the submitted documents
Regarding the import of medical devices or the distribution of second – hand medical devices, they are allowed only under the limiting situations stipulated by the Order, namely:
a) an individual or entity that buys for his own use a used medical device bearing CE markings and is obliged, prior to commissioning, to request ANMDM to verify its performance and its security in order to issue the functioning approval. In this case, the medical device must also have at the time of purchase, at least 3 years of normal life;
b) the importer / distributor of second-hand medical device bearing the CE marking declares the end user of the medical device and makes proof of its request, being obliged before commissioning to request ANMDM to verify the performance and security of the medical device, in order to release the functioning approval. In this case, the medical device must also have at the date of purchase at least 3 years of normal life. The importer / distributor undertakes to provide repair, maintenance, installation / commissioning and spare parts for that medical device;
c) the medical device is fully refurbished, has been certified as such (as a product bearing the CE marking as refurbished) and will be notified to ANMDM at the time of commissioning / marketing.