| Regulatory Authority | National Agency for Medicines and Medical Devices (NAMMD) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Directives and regulations | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Device Classification Guidelines |
MDCG 2021-24 Guidance on classification of medical devices | Click Here |
| Registration Process | Medical Device Registration | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Romanian Language |
| Clinical Trials Information |
The NAMMDR approves applications for conduct of clinical investigations and clinical performance studies only if accompanied by an ethical opinion issued by the National Bioethics Committee for Medicinal Products and Medical Devices (CNBMDM) | Click Here |
| Fees for Submission |
Tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in the field of medical devices. | Click Here |
| Declaration of Conformity |
In order to ensure compliance of medical devices with applicable requirements as well as their placing on the market according to the law, healthcare providers must request the manufacturer for compliance documents (the EC declaration of conformity and the conformity assessment certificate, as applicable). | Click Here |
| Certificate of Free Sale |
For the issuance of the free sale certificate for medical devices, respectively for in vitro diagnostic medical devices, the applicant submits to ANMDMR the application for the issuance of the free sale certificate for medical devices, respectively for in vitro diagnostic medical devices, completed with the data requested therein, together with the documents specified therein, as appropriate. | Click Here |
| Post Market Surveillance |
Cap II, Art.4: Healthcare professionals, patients, and users must report to the ANMDMR any suspected serious incident related to medical devices and in vitro diagnostic medical devices they handle, within a maximum of 15 days from the date the incident occurred, depending on the consequences caused. | Click Here |
| Reportable Incidents |
Incident Classification: 1. Death 2. Serious, unanticipated deterioration of health condition 3. Other reportable incident |
| Adverse Event Reporting Form | Download |
| Field Safety Corrective Action |
• Field Safety Corrective Action (FSCA) https://ec.europa.eu/docsroom/documents/32305/attachments/4/translations • Field Safety Notice (FSN) https://ec.europa.eu/docsroom/documents/32521 | Click Here |
| Additional Information | Forms and rates – Medical devices: https://www.anm.ro/dispozitive-medicale/formulare-si-tarife/ |