Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)
| Regulatory Authority | Bulgarian Drug Agency |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Medical Device Act | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Device Classification Guidelines | Article 2 (1 to 5) defines the rules for classification based on risk of class. | Click Here |
| Registration Process | Registration of medical devices | Click Here |
| Registration Timeline | For Class I, it is 2 to 3 months and for other classes, it depends on the notified body and type of product |
| Technical Documentation Format |
Manufacturers of medical devices shall prepare technical documentation the contents of which is determined in the relevant ordinances as per Art.18 of this act | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Bulgarian Language |
| Clinical Trials Information |
Notice to Sponsors of Clinical Trials | Click Here |
| Adverse Event Reporting Timelines | Article 106 of Medical Devices Act highlights the reporting timelines as the seriousness of the threat of an incident: |
| Additional Information | IAL provides data on the registration of the products upon request by regulatory authorities of other EU member states and the European Commission. |
| Contact Phone | +359 2 8903555 |
| Contact Email | bda@bda.bg |