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Questions & Answers

-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.
-Yes, you must. Having available technical file, different test reports for medical device, clinical evaluation the procedure of registration would be simplified.
-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.
-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.
-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.
-Necessary to assign authorised representative. Sign correspondent agreements and prepare technical file in compliance with requirements of Technical regulation.