Medical device
registration services

At RedMed, we provide a One-Stop solution on the Russian registration for medical products, ensuring that your device is compliant with all local regulations and standards.

Russian national healthcare Regulator – Roszdravnadzor – carries out the state approval of medical devices.

Registration for medical devices in Russia allows lowering your VAT when batch enters the country: usual 20% becomes 0% or 10%, if the product has the Registration and specific customs codification.

A process of registration briefly:

1. The works on the devices` registration begin after translating your technical file, operational manual, reports on usage to Russian.
2. Then we create a set of standardized documents good for both tests passing and for the Russian regulator. There are technical & toxicity tests conducted, then – clinical non-human, and an electromagnetic compatibility test required for devices powered by electricity. Before the tests you have to appoint an Authorized Representative in Russia – we are good to fulfill this role. The tests that you have passed in the country of origin, or in the US, EU aren`t accepted as a replacement for the tests, yet will be added to the devices` dossier for the regulator to confirm characteristics of the products.

The Russian and the EAEU state fees for the Registration of medical devices, paid before the dossier submitted:

State Letterhead for each registration

11 000 RUB

For conducting an examination of the quality, effectiveness and safety of medical devices (depending on the class of potential risk of their use) during state registration

• class 1 - 72 000 RUB;
• class 2а - 104 000 RUB;
• class 2b - 136 000 RUB;
• class 3 - 184 000 RUB.

3. When the tests ready, we add the test protocols to the dossier and then the manufacturer has to undergo an inspection of the Manufacturing site. Only devices of classes 2a sterile, 2b, 2b sterile and 3 fall for the inspection by the regulator`s branch institution team. In previous years, no inspection was conducted at all.

4 After the inspection protocol obtained, we submit the dossier to Roszdravnadzor. The regulator decides on issuing comments to the dossier in 30 days, and allows 50 days to eliminate them. Then RedMed resubmits the dossier, and the Regulator has 40 more days for the Registration Certificate issue.

With RedMed by your side, you have confidence in the success of registration. Check our latest succesfull cases, contact us for information.

Are you eager to expand your market reach to all the Eurasian Economic Union (EAEU) countries? The unified EAEU Registration certificate obtained at RedMed opens doors to sales at five states: Russia, Belarus, Armenia, Kyrgyzstan, and Kazakhstan, which population comes to 190 million.

You gain permanent validity and equal recognition across these countries, as well as lowering your VAT from 20% to 0-10%%.

While the registration procedure for the EAEU is currently conducted alongside individual national registrations, it is important to note that starting from January 1, 2026 the EAEU registration will be the only requirement in all of 5 nations–EAEU members.

Beyond mandatory tests passing (technical, toxicity, clinical non-human), sterile products in Class 2a and all devices in Classes 2b and 3 require an inspection of the manufacturer's production site by Regulator`s team. RedMed will guide you through this process, ensuring compliance and adherence to the highest standards.

During the registration, a comprehensive dossier will be formed. It includes essential documents such as technical file, user manual and labeling of transport and consumer packages. Additionally, laboratory test reports will be included after the completion of the tests.

A unified Authorized Representative holds all legal responsibility during your products circulation at the Five countries market.

Contact us today to get a road map with timings and a quote on the EAEU registrations, so we could help you to unlock the vast potential of the Five nations market.

When it comes to registering your product in CIS countries, you'll be pleased to know that each country has its own unique requirements and timelines, and RedMed is here to guide you through the process seamlessly.

Explore the key CIS countries:

KAZAKHSTAN registration of medical devices

• The registration is permanent for non-KZ devices.
• No requirement for local trials – manufacturer`s trials are good to go.
• Production site audit required unless you registered some devices earlier.
• Time to get the registration: as quick as 5-6 months.
• Authorized Representative: Local company only (we provide you with our company in Kazakhstan, Almaty).

BELARUS registration of medical devices

• Registration Certificate issued for 5 years with a simplified extension process.
• Some tests conducted earlier could be accepted, but the regulator decides on passing or not passing specific trials afterthe device`s techfile reviewed.
• Production site audit by Belarusian regulator specialists is required.
• Time to get the registration: up to 6 months.
• Authorized Representative: Russian companies allowed.

KYRGYZSTAN registration of medical devices

• The registration is permanent.
• Local technical and clinical trials of products are required.
• Production site audit could be required - up to regulators decision.
• Time to get the registration: as quick as 6 months.
• Authorized Representative: Kyrgyz company only (we provide you with our company in Kyrgyzstan, Bishkek)

UZBEKISTAN registration of medical devices

• Registration issued for 5 years, with a simplified extension process.
• Regulator conducts its own expertise of devices.
• Manufacturing site audit for high risk class devices could be required by regulator.
• Time to get the registration: up to 11 months.
• Authorized Representative: non-Uzbek companies allowed

AZERBAIJAN admission of medical devices

  National registration of medical devices is carried out beginning from Jan. 1, 2024. The registration certificate to be issued for 5 years.

• Until Dec. 31, 2023, the devices` batch is good to enter the country after the admission received.
• A letter of authorization and a hygienic certificate from the local authority required to get importation done. Our representative`s office in Azerbaijan will quickly do it for you. 
• Kindly note, that each batch of products requires this kind of one-time authorization.
• Time to get the admission: up to 1.5 months.

ARMENIA registration of medical devices

• National registration of medical devices is carried out under Decree 429-N dated 30.03.2023 and begins from Jan. 1, 2024. The regulator will conduct the devices` expertise.
• The EAEU procedure is active.

In all of the listed states, RedMed is your trusted partner for importing goods for testing, or for commercial purposes. We provide comprehensive assistance throughout the entire process, ensuring a smooth and efficient experience.

Don't navigate the registration process alone - contact us today for expert consultations, accurate calculations, and personalized roadmaps tailored to your specific needs - let us simplify your journey towards registration in CIS countries.

An Authorised Representative is an agent acting for legal compliance of your devices when undergoing registration, or having its Registration certificate issued already. It is a mandatory requirement like on many other markets, and set by state regulators. That service helps our Customers to avoid navigating the complex legal and reporting landscape - we take care of all regulatory requirements for medical products. It is important to note that RedMed's role as an Authorised Representative is solely focused on the devices` compliance: we do not participate in distribution processes, revenue management or marketing activities.

Our attention is strictly on regulatory matters that allows you confidently sell devices on the market while we manage functions below:

What is included in the Authorised Representative agreement for Russia/EAEU

Informing state bodies through the Automated Information System of Roszdravnadzor about each batch of medical devices imported into the territory of Russia/the EAEU – this allows the regulator to track each batch and apply restrictions if adverse effects arise.

Submission to Roszdravnadzor of an annual report on clinical monitoring and usage of medical devices of class 3 and implantable medical devices of class 2b.

Weekly check of international databases of information on adverse events related to a medical device. It includes informing the manufacturer about such events, developing a procedure for correcting documentation.

Informing the Manufacturer about the detection of adverse events on the territory of the Russian Federation / EAEU. Includes the development of a procedure for further actions for settlement.

Informing the Manufacturer about changes in regulatory acts (for example, taxation), includes the development of a procedure for further actions to bring the documentation of a medical device to the norm, coordination and prompt changes to the registration documents of a medical device when innovations in legislative regulation appear.

Receiving requests from consumers within Russia/EAEU via the communication channels indicated on the packaging of products, and processing, coordinating responses with the participation of the Manufacturer.

Notification of the Manufacturer about the need for a planned inspection of production (only for Medical devices registered under the EAEU procedure of classes 2a sterile, 2b, 3).

Notification of the Manufacturer about control and supervisory measures regarding the circulation of a medical device in Russia / EAEU with the issuance of recommendations for further actions.

At RedMed, we are also ready to assume partly regulatory compliance for those who is unexperienced in it:

• processing incoming requests and incidents reports and developing a professional position on responding to requests;
• support of regulatory authorities' requests and technical documents regular check;
• preparation and assistance in submitting periodic reports on the use of medical devices.

Our goal is to provide you with a hassle-free experience, allowing you to sell in Russia/EAEU with confidence.

One of our core services is assisting with selecting of test sites and developing test plans for technical, toxicity, clinical non-human tests, and electromagnetic compatibility trials. Our team of in vivo and in vitro experts will guide you through the entire process: from designing the tests plans and selecting a credible laboratory to proofreading and including the results into your device's dossier for regulatory bodies.

Rarely, medical devices might require a human testing. We understand the importance of human testing preparations, its timings and safe budget planning for your business. Our experts will facilitate smooth and efficient procedures in Test planning due to Russian/EAEU standards, populace selection, insurance plans choice and Ethical committee success within the Ministry of Healthcare. We are experienced in human testing while registering classes 2b and 3 new devices, and ready to help you with our truly unique experience.

We are dedicated to being your trusted partner throughout the entire tests passing process in Russia, EAEU and CIS.

RedMed ensures the seamless importation and distribution of your products across borders.

Our customs team handles the logistics, intra-EAEU handling and compliance with all necessary regulations for your samples and commercial batches of registered medical products. Our services go beyond just customs clearance - from picking up your products at the manufacturer's storage facility to delivering them to distributors in Russia, EAEU, or CIS countries. We understand the importance of timely and secure transportation. RedMed also offers transportation solutions in safe and efficient delivery of gases, both by air and on ground.

Contact us today to learn more about our full-service solution for samples and medical devices export to Russia, EAEU, and CIS countries.

We will develop or make changes to the following documents:

• Technical documentation of the product
• Operational documentation
• Document on the validation of the packaging process of a medical device
• Document confirming the expiration date (shelf-life report)
• Sterilization validation document
• Report on clinical monitoring of a medical device