Medical Devices Regulatory Support in Ukraine

Overview

Medical device registration in Ukraine is regulated by the State Administration on Medicines and Drugs Control, which is also the state market supervision authority. Medical devices are allowed for use in Ukraine only after conducting the procedure of conformity assessment. The Ministry of Economic Development and Trade of Ukraine is the central body of executive power, which ensures the formation of a state policy in the sphere of technical regulation.

Classification of Medical Devices

Medical devices are classified into classes, depending upon their risk levels. And the path opted for Medical device registration is totally dependent on categorization of devices.

  • Class I
  • Class IIa
  • Class IIb

Registration of Medical Devices

A foreign manufacturer must have His/her authorized representative with a registered office in Ukraine to carry out the documentation and other procedures. Medical device authorized representatives should be responsible for carrying out legal procedures regarding medical device approval with the MoH.

In Ukraine, ways of medical device conformity assessment are dependent on the category of the device and the risk level involved. Following are the types of procedures conducted for the respective categories/class of devices:

Self-declaration

Category of device - Non-sterile medical devices of class 1 without measuring functions, analyzers, reagents and other IVD products

  • Do not require submission of documents or any expertise procedures
  • Approval can be obtained through notification

Examination of Quality Assurance System including Inspection of Manufacturing site(s)

Category of device - Any type of classes I, IIa and IIb devices except for non-sterile devices of class I without measuring functions

  • Submit following documents and certification - Power of Attorney from the manufacturer to the authorized representative, clinical evaluation report, draft of declaration of conformity for Ukrainian market, risk management report, declaration of conformity to the relevant EU Directive requirements, initial labeling, draft of user manual, QMS certificate of conformity to the requirements of ISO 9001, ISO 13485 (if available)

Design Examination with Quality Assurance System and Inspection of Inspection of Manufacturing site(s)

Category of device - Class III devices, vitro diagnostics and active implantable medical devices

  • Along with the documents submitted for QA & manufacturing site inspection, certified copy of a technical file and certified copy of a design dossier for each product type included in the application.

Recognition through EC Certificate

Category of device - Sterile medical devices of any class, medical devices for in vitro diagnostic from List A, active implantable medical devices.

  • If a medical device manufacturer has an EC certificate issued by one of the notified bodies of the EU member states and the member state is in agreement with the Ukrainian agency for unilateral recognition of conformity assessment, the device can get approved without complex inspections. 
  • The documents required for EC recognition are similar the QA, design and manufacturing inspection with letter of confirmation from the EU notified body on the validity of certificate and, in some cases, with explanation of its scope.

Product Maintenance & Compliance

Sl. No

Validity of the conformity certificate

Validity of EC certificate

Renewal

01

Five (5) Years

Same as the certificate issued by the notified body of the EU Member State

Validity period of the conformity certificate can be extended for five (5) years

Freyr Expertise

  • Regulatory consultation and strategic support on submission roadmap
  • Authorized Agent support
  • Regulatory support for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support and Device registration
  • Dossier preparation, review, and management
  • Query Support Management till Approval
  • Product Information Leaflet (PIL)
  • Regulatory Labeling
  • Artwork Management
  • Ad-Hoc Regulatory Affairs Consultation
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