Ukraine
- Regulatory Authority:
Ministry of Health of Ukraine
State Administration of Ukraine for Medicinal Products
- Legislations:
Resolution of the Cabinet of Ministers of Ukraine No.753, 754, 755
EU MDR 2017/745
- Registration period:
1–2 months
Class I
3–5 months
Class IIa and IIb
- Certificate validity period:
5 years
- Language of labeling and documentation:
Ukrainian
- Authorized representative:
country resident
A brief algorithm for registration of medical devices in Ukraine:
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Class I devices can be certified independently. IIa and IIb classes require a Regulatory Authority for conformity assessment
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