New medical device regulations planned in Ukraine

11/20/2013 | MassDevice.com (Boston)

In an effort to align more closely to EU requirements, Ukraine is planning changes to its medical device regulatory system early next year. Among the new requirements are the appointment of Ukraine-based representatives by foreign registrants, special national conformity symbols for devices imported into the country on or after Jan. 7, and manufacturing site inspections for Class I, IIa, IIb and III devices. The new system will not offer expedited registration for devices already approved in major markets. Manufacturers with current authorizations will have a transition period to comply with the new regulations.

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