Ministry of Health

Ministry of Health of Ukraine

Regulatory Authority

State Administration of Ukraine on Medicinal Products (SAUMP)

Medical Device Regulation

Resolution by Cabinet of Ministry of Ukraine №753, 754, 755

EU MDR 2017/745

Official Language

Ukrainian

Classification

Class I, IIa, IIb and III

Registration Process

• Determine the device classification
• Appoint an Authorized Representative and Notarized Body
• Implement the Quality Management System (QMS)
• Prepare the Technical File and Declaration of Conformity (DoC)
• Class I devices can be self-certified. Others need a Notified Body to carry out the Conformity Assessment
• Once approved by the Competent Authority, the device can be marketed in Ukraine

Documents Required

• Application Form
• Power of Attorney
• QMS certificate
• CE certificate
• Declaration of Conformity
• Technical File
• Product Description
• Label, IFU, User Manuals
• Risk Management Plan
• Clinical Studies Report
• Manufacturer’s business registration

Applicable QMS

ISO 13485

Registration Timeline

Conformity Assessment Procedure – 2-3 months

Batch verification procedure – 2-3 weeks

Authorized Representative

Yes.

License Validity

5 years