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

Classification:

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:

Yes 

License Validity:       

5 years

Special Notes:          

Documents to be submitted in Russian