Medical Device Registration in


Medical device registration in Belarus

Ministry of Health:   

Ministry of Healthcare

Regulatory Authority:         

Department of Medical Equipment of Centre for Examinations and Tests in Health Service (NCE)

Medical Device Regulation:

Resolution 504

Official Language:    

Belarusian and Russian


Class I, IIa, IIb and III

Medical Device Registration in Belarus:           

  • Determine the classification of the device.
  • Appoint Authorized Representative.
  • Assessment of documents and preparation of registration dossier.
  • MoH reviews the submitted documents and if approved issues the Registration certificate.
  • The manufacturer can then place the device on the Belarus market

Documents Required:         

  • CE Mark certificate
  • Registration Dossier
  • Appointment letter of Authorized Representative

Registration Timeline:         

Medical device – 3 months

Medical equipment – 5 months

Authorized Representative:


License Validity:       

5 years

Special Notes:          

Documents to be submitted in Russian


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