Following our partnership earlier in the year with our new Russian distributor Kraftway, Gate Dental Services is delighted to announce an increase of sales orders coming from Russia as a result of Dental Expo, Moscow 2014. Initial feedback and preorders already suggests that the Russians see “a great benefit in using our dental bur holders and with a second large order being dispatched in the coming days it looks as if DentalOrganiser products are a great success with Russian dentists.
The registration of medical devices and medical equipment in Russia is challenging. Russia has its own national standards of testing which is required for products that might already have CE (Europe) marking, US Food and Drug Administration clearance or other national approvals. Even products that have been for sale on the US and European markets for many years require product testing to Russian standards as well.
Russian product testing in addition to obvious language issues are significant barriers for foreign companies to register medical equipment in the country. Since very few documents exist in English, it makes sense to operate through a local business partner familiar with the process.