Russian Federation

Medical Device Registration in the Russian Federation (Government Statement № 1684) Standard *registration period is up to 12 months

Development of technical and operational documentation for PP 1684

Maintenance of technical tests

Support of toxicological tests

Clinical trial support

Collecting the registration dossier and submitting it to Roszdravnadzor

Popular

Medical Device Registration in the Russian Federation (Government Decree № 1684) Pro *registration period is up to 10 months

In addition to the standard package:

Revision of drawings and design documentation

Formation of the composition of a medical device according to the requirements of 44 FL and 223 FL

Medical Device Registration in the Russian Federation (Government Decree № 1684) Business *registration period is up to 8 months

In addition to the Pro package:

Collecting a complete set of dossiers for transmission to the Customer in electronic and paper form

Providing market analytics

Consulting support of the RU holder throughout the year

Manufacturer's trademark protection

Development of production processes for packaging and production of MD

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Contacts

Office in St. Petersburg

St. Petersburg, st. Mozhaiskaya, 17