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Registration of medical devices in Ukraine

  July 1, 2015 in Ukraine was the start of the procedure - conformity assessment of medical devices to technical regulations.

There are three regulations:

-assessment conformity of medical devices – resolution by Cabinet of Ministry of Ukraine №753 from 02.10.2013

-assessment conformity of in vitro diagnostic devices - resolution by Cabinet of Ministry of Ukraine №754 from 02.10.2013

-assessment conformity of active implantable devices - resolution by Cabinet of Ministry of Ukraine №755 from 02.10.2013

The registration procedure of medical devices (conformity assessment) in Ukraine is determined by the risk class of the medical device. Medical devices in Ukraine are divided into the same classes of risk that adopted in the EU, - I, IIa, IIb, III. For devices of class I risk not sterile and non measurement registration procedure is the simplest and is essentially self declaration. Devices of  Is, Im, IIa, IIb, III class risk - may require an audit of the production site or tests for products.

The registration procedure can be divided into the following stages:

-search and appointment of authorized representative

-selection the conformity assessment body

-determination of conformity assessment route

-preparation of technical documentation (technical file)

-submission of documentation

-audit of the production or lot/medical device verificaton

-getting certificate

-applying of national mark of conformity 

The documentation to be provided is determined by the class of risk and the performance of the device and may vary. But the overall list looks like this:

- Agreement between manufacturer and its authorized representative in Ukraine

- List of all modifications, models, parts, disposables

- Instructions for use, user’s manual, technical characteristics.

- List of applicable standards.

- Report and results of the risk analysis. 

- Brochure (description of the device with a photo), catalogue of devices, any advertising materials. 

- EC Declaration of conformity (or similar documents)

- Certificates ISO 9001; ISO 13485. 

- Documentation of the quality system 

- All available information on safety and efficiency of medical device: protocols, reports of the preclinical and clinical studies, other studies and scientific information.

- If sterility is applied - certificate of sterility, description and validation of sterilization method.  

- Package labeling information.

 We provide consultancy on each stage of device registration. Please, contact us with description of your device on s.kharchenko@yahoo.com to get more info how to proceed.