Get In Touch:

Bulgaria

Medical Device Registration in Bulgaria

Ministry of Health:

Ministry of Health

Regulatory Authority:       

Bulgarian Drug Agency

Medical Device Regulation:

EU MDR 2017/745

Medical Devices Act, 2007

Official Language:   

Bulgarian

Classification:        

Class I, IIa, IIb and III

Registration Process:       

  • 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.

Want to know more about this registration process?