12.11.2024
To the attention of economic operators approved by the National Agency for Medicines and Medical Devices of Romania who carry out activities in the field of medical devices
In line with Order of the Minister of Health no. 566/2020 on approval of the Methodological rules for application of Title XX of Law 95/2006 on healthcare reform, the marketing activities and the activities related to the provision of services in the field of medical devices subject to control by approval are the following:
a) the import of medical devices;
b) the distribution of medical devices;
c) the installation and/or maintenance of medical devices.
The operation permit issued in accordance with Order of the Minister of Health no. 566/2020 is valid for a 3-year period from the date of issuance, if the conditions on which the permit was issued remain unchanged. The validity of this permit ceases on the date of issuance of the new operation permit.