| Application/Notification for grant of operation notice on medical device-related activities download document …  download document …  |
| Application for change of operation notice on medical device-related activities download document … download document … |
| Application/Notification for record into the national database of EU/EEA resident medical device service providers download document … download document … |
| Application for grant of notice for use of medical devices descarca documentul … descarca documentul … |
| Application for grant of periodic check bulletin for medical devices download document … download document … |
| Application for grant of periodic check bulletin for medical devices in use by mobile intervention units download document … download document … |
| Application for grant of notice for use of medical devices in use by mobile intervention units download document … download document … |
| Application for grant of notice for use of diagnostic and therapeutic medical devices by ionising radiation, nuclear medicine and MRI download document … download document … |
| Application for grant of periodic check bulletin for diagnostic and therapeutic medical devices by ionising radiation, nuclear medicine and MRI download document … download document … |
| Application for grant of periodic check bulletin for medical devices radioprotection equipment download document … download document … |
| Application for issuance of a customs notice download document … download document … |
| Application for grant of out-of-scope notice download document … download document … |
| Payment form grant of out-of-scope notice – customs notice descarca documentul … descarca documentul … |
| Form – Report on medical device related incidents – for users download document … download document … |
| Form – Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) Reporting Template Version 7.2.1 download document … |
| Application for clinical investigation download document … download document … |
| Contents of the clinical investigation dossier download document … download document … |
| Application for standard classification of a product, complex classification for a borderline product, classification challenge download document … download document … |
| Application for the issuance of a certificate of free sale of medical devices download document … download document … |
| Application for the issuance of a grant of donation notice download document … |
| Application for the issuance of an out of scope notice download document … download document … |
| F.CMD – Notification form for placing on the market of custom-made devices download document … download document … |
| F.MDIVD_IS – Notification form for medical devices in vitro diagnostic medical devices manufactured and used within healthcare institutions download document … download document … |
| Fee payment form – DESIGNATION OR MONITORING OF MEDICAL DEVICE CONFORMITY ASSESSMENT BODY download document … download document … |
| Fee payment form – EVALUATION OF THE NOTIFICATION FILE OF MEDICAL DEVICES MANUFACTURED AND USED WITHIN PUBLIC OR PRIVATE HEALTHCARE UNITS EVALUATION OF THE NOTIFICATION FILE OF A MODIFICATION download document … download document … |
| Fee payment form – FREE SALE download document … download document … |
| Fee payment form – Issuance of an out-of-scope notice download document … download document … |
| Fee payment form – ISSUANCE OF CUSTOMS NOTICE download document … download document … |
| Fee payment form – ISSUE OF AN ORIGINAL DOCUMENT AT THE APPLICANT’S REQUEST download document … download document … |
| Fee payment form – NATIONAL DATABASE SEARCH FEE download document … download document … |
| Fee payment form – STANDARD PRODUCT CLASSIFICATION, CLASSIFICATION DISPUTE, (COMPLEX) CLASSIFICATION FOR A BORDERLINE PRODUCT download document … download document … |
| Fee payment form – Validation_Verification of registration in the European Database on Medical Devices (Eudamed) download document … download document … |
| Fee payment form – ISSUE OF CERTIFICATE OF REGISTRATION OF MEDICAL DEVICES IN THE NATIONAL DATABASE REGISTRATION OF MODIFICATION OF INFORMATION IN THE DATABASE WITH MEDICAL DEVICES download document … download document … |
| Form F1 – Notification form for placing medical devices on the market download document … download document … |
| Form F2 – Notification form for the placing on the market of in vitro diagnostic medical devices download document … download document … |
| Form F3 – Application form for derogation from conformity assessment procedures download document … download document … |
| Form F3 IVD – Form for requesting derogation from conformity assessment procedures download document … download document … |
| Form F4 – Form requesting approval for the exemption of the translation into Romanian of the information provided by the manufacturer together with the medical device download document … download document … |
| Form F4 IVD – Form requesting an opinion for the exemption of the translation into Romanian of the information provided by the manufacturer together with the in vitro diagnostic medical device download document … download document … |
| Form F5 – Information form under Article 16 of Regulation (EU) 2017 745 download document … download document … |
| Form F5 IVD – Information form under Article 16 of Regulation (EU) 2017 746 download document … download document … |
National Agency for Medicines and Medical Devices of Romania
