Medical Device Regulatory Requirements in Bulgaria
| 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
|
| 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 |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Bulgarian Language |
| 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. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025