registration. certification. distribution.- · registration. key points. medical devices and...
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Some tips to succeed in the Russian Medical Device Market
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Registration. Certification. Distribution.-
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Your Success
in Russia
Your Success
in Russia
Reliable Distributor in
Russia
Reliable Distributor in
Russia
Russian Market
Understanding
Russian Market
Understanding
Registration and
Certification
Registration and
Certification
3 Keys of Success
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• Population: more than 142 mln;
• GDP US $2 trillion;
• One of the top 20 largest medical markets in the world;
• Total turnover = US $5.6 bn.;
• Annual market growth of 13.8% in next 5 years.
Russian Medical Device Market
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Russian Medical Device Market
Up to 81% Medical devices are imported.
Largest share of import:
high-tech market segments, i.e.
• Diagnostic imaging devices;
• Nuclear medcine;
• Neurosurgery;
• Cardiosurgery;
• Telemedicine.
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Russian Medical Device Market.
State Hospitals
• Strong in hospital infrastructure;
• Up to 90% of medical device market;
• Sales by state tenders .
Private Clinics
• Present primarily in big cities, with specialization in: dentistry, aesthetic and plastic surgery, ophthalmic surgery;
• A fast growing sector.
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Russian Medical Device Market.
TIPS
• Investigate your market potential in
Russia with the help of specialized local agency;
• Request Market and Product Profiles.
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Reliable Distributor in Russia.
• Sales to State Clinics by Tenders- over 80% of the Medical Device Market;
• Distributor network;
• Work with local KOLs, Key clinics;
• Participation in local congresses and exhibitions;
• Market intelligence ;
• After sales (service, spare parts stock).
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• Invest your time in knowing your potential distributor better, visit local exhibition or congress;
• Trust but check > Never assume ;
• Gain some knowledge of the Russian language and culture;
• Use a specialized agency to find the reliable distributor or request a profile of the potential partner.
TIPS
Reliable Distributor in Russia.
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Registration. Key points.
Medical devices and medical equipment can be sold in Russia only with Registration Certificate and Certificate of Conformity( GOST).
The registration process must be completed through Roszdravnadzor- RZN and is based on the results of testing.
Test results obtained in other countries are not accepted. New testing within the Russian Federation is needed.
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Registration. Key points.
Testing ( toxicological, electrical safety, clinical etc ), are performed by authorized institutions within Russia.
Preparation of complete and precise Dossier is the key to successful registration.
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Registration. Key points.
DURATION: 10-12 months
COST: USD 12, 000- 15,000 per each Registration Certificate
PERFORMED BY: Authorized Russian company appointed by the Japanese supplier
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Registration.
Registration On Japanese Supplier’s Name
Registration On Distributor’s Name
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Certification. Obtaining the Certificate of Conformity.
Issued after receiving the Registration Certificate
Duration: not more than 7 days
Cost: USD150
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Registration and Certification.
• Make sure you know the actual list of necessary documents, and your documents look as close to sample as possible;
• Find a reliable registration consultant.
TIPS
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STAY CONNECTED!!
FREE WEBINARS IN JAPANESE
• Russian Medical Device Market is lucrative, fast growing and extremely attractive;
• Better understanding of the Russian culture, market situation, as well as the registration procedure will help you succeed!
Contact Us to paticipate
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