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Approval of medical devices in Ukraine(英語)

医療機器市場における承認に確信を

What is involved in the certification of medical devices in Ukraine?

Certification of medical devices in Ukraine requires organisations to adhere to Ukraine’s medical device regulations. In July 2017, Ukraine introduced new medical device regulations which are identical to European directives for medical and IVD devices; and also issued a new national conformity mark. Therefore, device manufacturers that intend to introduce their product to the Ukrainian market must demonstrate that it follows these requirements. 

WHY is conformity to the Ukraine medical device regulations important?  

Ensuring that your medical device meets the Ukrainian requirements is essential for the following reasons:

  • Market access – to legally sell a medical device in Ukraine it must include a national conformity mark
  • Boost customer and patient trust – conformity demonstrates that your brand is committed to safety and quality
  • Avoid fines for non-compliance – failing to conform to the standards may result in fines and loss of reputation

TÜV SÜD has in-depth knowledge of the Ukraine medical device regulations

TÜV SÜD has worked closely with the Ukraine conformity assessment bodies to provide support for Ukraine conformity assessment of medical devices. 

TÜV SÜD experts have first-hand knowledge of current regulations affecting medical device access to the Ukraine market and maintain communication with conformity assessment bodies. In addition, TÜV SÜD’s expertise in global medical device technical and regulatory issues can ease the product approval process in Ukraine and other countries.

Our support during the Ukraine medical device certification process

The certification of medical devices in Ukraine is made easy with the support of TÜV SÜD, in two simple steps: 

  1. TÜV SÜD issues a document which confirms that medical devices intended for the Ukraine market have been certified by TÜV SÜD and are covered by valid EC product certificates.
  2. This document forms the basis for Ukrainian conformity assessment bodies to issue conformity certificates for Ukrainian market access. This means the medical device manufacturers can avoid additional audits by the Ukrainian conformity assessment bodies and therefore allows for much faster and straightforward certification.

TÜV SÜD has signed agreements with several Ukrainian conformity assessment bodies and is ready to include additional ones.

 

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