Medical Device Registration in

Ukraine

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

 

 

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