;   Medical Translation Insight: Regulatory requirements for selling medical devices in the Ukraine - ForeignExchange Translations

Regulatory requirements for selling medical devices in the UkraineEven though Ukraine is the second largest country in Europe and has a population of close to 50 million people, its domestic market for medical equipment and supplies is estimated at only US$281 million. Small, for sure, but the market is expected grow at a CAGR of 6.4% annually. Increasingly, the country is gaining the attention of medical devices companies looking for new and emerging markets.

As part of its effort to try and gain EU membership, Ukraine is busy harmonizing its regulations, including those for medical devices. Importantly, Russian certifications (such as GOST-R) carry no weight in Ukraine.

For up-to-date regulations, Bureau "Cratia" is the primary source of information. It contains extensive English resources, although the English can be a bit rough at times.

Details around medical device registrations are generally useful:

State registration of medical device is an obligatory requirement for import, sale and marketing of device in Ukraine. State registration is performed centralized in Department of regulatory policy of medicinal products and goods of healthcare area of Ministry of Health of Ukraine that is located in Kiev.

Registered medical device is included to the State registry of medical devices of Ukraine. Registration certificate of medical device is issued for 5 years and can be renewed before expiry. Application for renewal of registration should be submitted not later than 90 days before the date of the expiry of registration certificate.
Bureau "Cratia" also provides a good overviews of new device registrations, registration renewals, and the structure of registration dossiers.

For more market-specific regulatory news, take a look at:
For expert translations of regulatory submissions, packaging, and labeling in 40 languages - including Ukrainian - request a detailed proposal from ForeignExchange Translations.

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