Medical Device Registration in
Ministry of Health:
Department of Medical Equipment of Centre for Examinations and Tests in Health Service (NCE)
Medical Device Regulation:
Belarusian and Russian
Class I, IIa, IIb and III
- 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
- CE Mark certificate
- Registration Dossier
- Appointment letter of Authorized Representative
Medical device – 3 months
Medical equipment – 5 months
Documents to be submitted in Russian