Medical Device Registration in
Bulgaria
Ministry of Health:
Regulatory Authority:
Medical Device Regulation:
EU MDR 2017/745
Medical Devices Act, 2007
Official Language:
Bulgarian
Classification:
Class I, IIa, IIb and III
Medical Device Registration in Bulgaria:
- Determine the classification of the device
- Implement QMS in accordance to ISO 13485
- Prepare and submit the Technical File
- Appoint EC Representative
- Medical devices must be CE marked.
- Register with competent authorities
- Once approved, the manufacturer may market the medical device.
Documents Required:
- Manufacturer business registration
- QMS ISO 13485 certificate
- CE certificate
- EC Declaration of Conformity (DoC)
- IFU in Bulgarian
- Risk Management File as per ISO 14971
- Clinical Evaluation
- Post-market surveillance
- Biocompatibility as per ISO 10993
- Product manufacturing flowchart
- Test reports
- Technical File
Post-market surveillance:
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Applicable QMS:
ISO 13485
Registration Timeline:
Class I – 6 weeks. Other depends on the type of the product.
Authorized Representative:
Yes. EC Representative
License Validity:
5 years
Special Notes:
IFUs and labels must be in Bulgarian.
Professional use documents can be in English.