Russian manufacturers
We register new devices, amend existing certificates and issue certificates and declarations of conformity.
For manufacturers, importers and distributors
Medical deviceregistration &certification
Registration certificates, certificates and declarations of conformity, testing and expert review. We prepare the full document package for Russian and foreign manufacturers, importers, distributors and companies.
RCRegistration certificate
EACCertificates & declarations
RU · CNFor Russian and Chinese companies
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We handle the registration and certification of medical devices in Russia: documents, testing, expert review and permits. Whether you are a factory, an importer or a company with one device, you get the result and we do the whole journey for you.
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risk classes: 1, 2a, 2b and 3. We register devices of any class
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account manager from the first request to the registration certificate
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working languages: Russian, Chinese, English
3000 m²
of our own warehouse if your device needs storage
Who we help
For factories, importers and beyond
Whether you make the device yourself, import it or need to certify a single unit, we prepare the documents and obtain the approval.
Importers & distributors
We obtain registration certificates and conformity certificates for devices you import from China, Europe and elsewhere.
Foreign factories
We act as your authorized representative in Russia and run the registration from start to finish.
Companies with one device
Need approval for a specific device to sell or use? We will take on even a single item.
Services
Registration, certification and documents, end to end
We take on the whole project or a single stage, from one declaration to registering a class 3 device. Each area is run by a specialist, while you deal with one account manager.
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Medical device registration
Registration certificates from Roszdravnadzor under national and EAEU rules for Russian and imported devices of every risk class.
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Certification & declarations
EAEU declarations and certificates of conformity (EAC), voluntary GOST R certification, exemption letters for customs and marketplaces.
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Testing & expert review
We arrange technical, toxicological, EMC and clinical testing at accredited centres and support the expert review through to a positive opinion.
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Documents, end to end
We prepare the technical file, instructions, labelling and all regulator forms, translate from Chinese and English and check documents you already have.
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Certificate amendments
We amend existing registration certificates: new models, configurations, manufacturing site or applicant, and re-issue certificates under EAEU rules.
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Consulting & assessment
We define the risk class and which document your device needs: a registration certificate, a certificate or a declaration. We estimate timing and budget. The first assessment is free.
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Authorized representative
We represent foreign manufacturers in Russia: we file documents, handle correspondence with Roszdravnadzor and post-market surveillance.
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Customs & foreign trade
Customs clearance of medical devices, HS code classification, duty calculation and import support.
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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 China and other countries to our Moscow warehouse, then on to clinics and distributors across Russia.
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Sales & distribution
If needed, we help sell the registered device through our clinic and distributor network and public tenders.
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Other services
Post-registration support, safety monitoring 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, the same for a factory, an importer or a company with one device.
- 01
Brief & assessment
We study the device, define its risk class and which document it needs: a registration certificate, a certificate or a declaration. We give you a timeline and budget.
- 02
Documents
We compile and check the dossier, translate the manufacturer's documents and prepare instructions and labelling in Russian.
- 03
Testing
We arrange 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 and issue certificates and declarations of conformity.
- 06
Ongoing support
We amend the certificate, help with import and, if needed, take on warehousing, logistics and sales.
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 enter the Russian market. We prepare the full document package, obtain the registration certificate and conformity certificates, act as your representative and find you a distributor.
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.
Roszdravnadzor registrationEquipment certificationDocuments & translationCustoms clearanceWarehousingLogistics across RussiaFinding clientsSelling your equipment
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 and importers gain approvals and a market, clinics gain equipment and distributors gain registered products.
Manufacturers
We will register and certify your device in Russia.
Importers & distributors
Registration and conformity certificates for the devices you import, plus help with supply.
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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Documents, end to end
We prepare, translate and check the whole package ourselves, from the dossier to answers for the experts.
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Transparency
A fixed estimate, clear stages and regular reports.
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Speed
We run documents and testing in parallel to get the result sooner.
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For any client
We work with Russian and Chinese factories, importers and companies with a single device.
FAQ
Frequently asked questions
Yes. Medical devices can only be sold in Russia after state registration with Roszdravnadzor, and some also need a certificate or declaration of conformity. We will work out what your device needs and prepare everything to obtain it.
Yes. The certificate is issued in the manufacturer's name, and a Russian company can file as its authorized representative. We will help you get the power of attorney and documents from the manufacturer and complete the registration.
Yes. We work with factories and with small companies alike. We will determine which document your device needs, a registration certificate, a certificate or a declaration, and obtain it.
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. For example, only testing, only the dossier or only certificate amendments. A full-cycle contract costs less.
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