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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.
Ensuring that your medical device meets the Ukrainian requirements is essential for the following reasons:
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.
The certification of medical devices in Ukraine is made easy with the support of TÜV SÜD, in two simple steps:
TÜV SÜD has signed agreements with several Ukrainian conformity assessment bodies and is ready to include additional ones.
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