Questions and answers

Questions and answers

How carrying out the registration of medical devices in Ukraine?

Since 01.07.15 the procedure of registration of medical devices is called as compliance assessment to Technical regulations. The registration procedure is similar with procedure of CE mark receiving in EU.

Medical device has CE mark, is it necessary to pass again the procedure of registration in Ukraine?

Yes, you must. Having available technical file, different test reports for medical device, clinical evaluation the procedure of registration would be simplified.

If medical device does not have CE mark but approved in my country, how to proceed with registration in this case?

Has to be prepared technical file on base of manufacture’s documents. Will be carried out laboratory tests on safety of medical device. Also would require clinical evaluation.

If my device is of dual purpose, might be as medical, is it compulsory to register it?

Does not compulsory. But such registration has many advantages as its sale to medicine organizations as possibility to import it with payment of preferential rate of VAT.

How long it will take to register medical device in Ukraine?

For medical devices of I class risk (non sterile, non measure) it takes from 2 weeks till one month. Lot/medical device verification – 2 months. In case of full quality system assurance 4-6 months.

I’d like to register medical device in Ukraine, how should I start?

Necessary to assign authorised representative. Sign correspondent agreements and prepare technical file in compliance with requirements of Technical regulation.

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