Import permit requirement:
Medical devices may only be imported into Russia subject to an import permit and for the purpose of their state registration (which is compulsory for all medical devices).
The issue of import permits for medical devices is regulated by Rules adopted by Order of the Ministry of Healthcare No. 7n of 15 June 2012.
Which authority?
The import permit for a medical device is issued by the Federal Healthcare Supervision Service (Roszdravnadzor).
Who may import medical devices for the purpose of state registration?
The manufacturer OR the person authorised by the manufacturer which is a company or a sole trader registered in the Russian Federation and authorised by the manufacturer to represent its interests on this matter (the Applicant). The registration certificate will be issued in the name of the Applicant.
How many units of medical devices may be imported into Russia for the purpose of state registration?
The Applicant decides on the number of sample devices which is to be imported into Russia for the purpose of state registration, taking into consideration the recommendations of organisations which are to perform technical, clinical, toxicological and other testing of the devices as well the necessity to test the devices for the purposes of compliance with state measurement devices regulations (if applicable), and depending on the potential risk class of the devices and the scope of required testing.