By Stewart Eisenhart, Emergo Group
Regulators in Ukraine will implement significant reforms to the country’s medical device registration system in early 2014 in order to better align market authorization requirements with those of the European Union, Emergo Group has learned.
The new system will utilize national conformity assessments similar to those used by EU regulators, and also introduces the following requirements for Ukrainian medical device registrations:
- Foreign registrants must appoint Authorized Representatives based in Ukraine
- Expanded list of documentation and sample submissions required for registrations
- Manufacturing site inspections for Classes I, IIa, IIb and III
- Special symbols of national conformity will be required for medical devices imported into Ukraine on or after 7 January 2014
- National conformity certifications valid for five years
Ukrainian officials plan a transition period for manufacturers that have already obtained market authorization; authorizations that are currently valid will remain so either for the next three years or until their expiration dates, whichever come sooner.
Although the new Ukrainian registration system will bear many similarities to the CE Marking process for medical devices in Europe, no simplified or expedited market pathways are planned for devices already approved or cleared for sale in major markets such as Europe or the US. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities even if those sites are already ISO 13485-compliant.
Application fees will likely increase once the new market authorization system is in place, but by how much remains unclear. We will provide more details as we get them.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.