ENG

More than 10 years of experience in medical devices regulatory affairs field

Professional registration of foreign medical devices

Regular monitoring of current changes in the sphere of medical device circulation in the legislation of the Russian Federation and the EAEU

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We provide a wide range of services, including not only obtaining registration certificates and making changes to already received registration certificates, but also:

Preparation and submission of letters and appeals to Roszdravnadzor and expert organizations on any issues

Correction of technical errors and typos in registration certificates

Consultations on any regulatory issues with references to legislation

Request of registration dossiers from the archive of Roszdravnadzor

Determination of nomenclature classification code in accordance to EAEU legislation

Consultations on the circulation of medical devices in the Russian Federation and the EAEU for foreign manufacturers in English language in any convenient format

Preliminary assessment of device to the category of medical products