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Medical device registration
Registration certificates from Roszdravnadzor under EAEU rules for devices of every risk class. Amendments to existing certificates.
Moscow · all of Russia · China
We bring medicaldevices to the marketof Russia
Registration and certification, a 3,000 m² warehouse, customs clearance, logistics and sales of medical equipment. One partner for the whole journey, from technical files to delivery at the clinic.
RCRegistration certificate
3,000 m²Own warehouse
RUDelivery to every region
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We take care of a medical device's entire journey in Russia: documents, certificates, customs, storage, delivery and sales. The manufacturer focuses on making great products, and we open the market for them.
3000 m²
of warehouse space for medical devices
4
risk classes we handle: 1, 2a, 2b and 3
3
working languages: Russian, Chinese, English
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contract for the full cycle, from paperwork to sales
Services
Everything you need to sell medical devices in Russia
We take on the whole project or a single stage. Each service is run by a specialist, while you deal with one account manager.
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Certification & declarations
EAEU declarations and certificates of conformity (EAC), voluntary GOST R certification, exemption letters for customs.
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Documents & translation
Technical and user documentation prepared to Russian requirements, with professional translation from Chinese and English.
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Testing & clinical trials
Technical, toxicological and EMC testing and clinical trials, arranged at accredited centres.
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Authorized representative
We act as the foreign manufacturer's representative in Russia, handle correspondence with the regulator and post-market surveillance.
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Customs & foreign trade
Customs clearance of medical equipment, HS code classification, duty calculation and import support from China.
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3,000 m² warehouse
Safe storage of any medical devices, goods receipt, labelling, order picking and stock tracking in a WMS.
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Logistics & delivery
Delivery from the factory in China to our Moscow warehouse, then on to clinics and distributors in every region of Russia.
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Sales & distribution
We sell and distribute medical equipment and products through our clinic and distributor network and public tenders.
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Finding new clients
We help you find new buyers, grow your customer base and enter new regions, with introductions to clinics and procurement teams.
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Marketing & market entry
Market and competitor research, positioning, Russian-language presentations and trade show participation.
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Other services
Post-registration support, servicing and legal advice. Tell us what you need and we will find a solution.
How we work
From the factory to the patient
Six stages we go through together with the manufacturer.
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Brief & assessment
We study the device, define its risk class, timeline, budget and the best route to market.
- 02
Documents
We compile and translate the technical file and prepare instructions and labelling in Russian.
- 03
Testing
We import samples and run technical, toxicological and clinical testing in accredited laboratories.
- 04
Expert review
We file with Roszdravnadzor, answer the experts' queries and see the case through to a decision.
- 05
Registration
We obtain the registration certificate, declarations and import permits.
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Warehouse & sales
We clear shipments, store them in our 3,000 m² warehouse, deliver across Russia and sell through our network.
For Chinese manufacturers
俄罗斯市场正在等待您的设备
The Russian market is waiting for your equipment
MedKoi helps Chinese factories grow their sales in Russia. We find a distributor and representative for you, prepare the full document package, obtain the registration certificate and expand the market for your products.
Distributor & representativeWe find reliable distributors and act as your authorized representative in Russia.
Full document packageWe translate your dossier from Chinese, prepare everything for Roszdravnadzor and obtain the certificate.
Sales across RussiaA 3,000 m² warehouse, logistics, a clinic database and tenders, all to grow your sales.
We speak your languageChinese-speaking managers, communication via WeChat and e-mail.
We are interested in any product your factory makes
Equipment, consumables and devices of every risk class. We handle the full cycle and the whole range of work so that your factory earns more.
Equipment certificationCustoms clearanceWarehousingLogistics across RussiaFinding clientsExpanding your marketSelling your equipmentHigher factory revenue
Warehouse
3,000 m² for storing medical devices
Our own warehouse near Moscow. We store equipment, consumables and any medical devices under the required storage conditions.
3000 m²total area
3,000 m²total area
WMSbatch and expiry tracking
24/7security and CCTV
°Ctemperature-controlled zones
- Goods receipt and inspection
- Safe custody storage
- Labelling and relabelling
- Order picking and dispatch
- Cross-docking
- Returns and disposal
Logistics & clinic network
Delivery to any point in Russia
From Moscow we deliver medical devices to every region, and we know who to sell them to: we have a database of clinics and medical institutions across the country.
Moscow office
All infrastructure and the team in one place.
Clinic database
Public and private clinics in every federal district.
Shipping from China
Road, rail and air. Consolidation and insurance.
Partnership
We are looking for partners
We are building a network where everyone wins: manufacturers gain a market, clinics gain equipment and distributors gain products.
Manufacturers
We will register and sell your device in Russia.
Distributors
Certified equipment supplied from our Moscow warehouse.
Clinics
Modern equipment directly from manufacturers.
Logistics companies
Joint routes across Russia and from China.
Why MedKoi
Like the koi: we guide your device to success smoothly and surely
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Full cycle
Documents, customs, storage, logistics and sales in one pair of hands.
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Transparency
A fixed estimate, clear stages and regular reports.
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Speed
We run documents, testing and sales preparation in parallel.
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A bridge to China
We understand how Chinese factories work and speak their language.
FAQ
Frequently asked questions
Yes. Medical devices can only be sold in Russia after state registration with Roszdravnadzor. We will define the risk class and prepare everything needed for the registration certificate.
It depends on the risk class, the scope of testing and how ready the documents are. After assessing the device we give you a timeline and budget and fix them in the contract.
Yes. MedKoi can act as your authorized representative and also take care of import, storage and sales.
Of course. Any service can be ordered separately, and a full-cycle contract costs less.
Yes, it is our strength. We sell equipment through our clinic and distributor network across Russia and take part in tenders.
Contact
Tell us about your device
We reply within one business day, and the project assessment is free.
E-mailinfo@medkoi.comWeChat: medkoi
Phone+7 (000) 000-00-00Mon–Fri, 9:00–18:00 (MSK)
OfficeMoscow, address to be confirmed