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Registration of medical devices

Registration of medical devices

Get a registration certificate in 10 months – without refusals and improvements
We guarantee the result or refund of part of the payments!

10% discount on all services until October 1, 2026! We will analyze your documentation as a gift.

Medical Device Registration in the Russian Federation (Government Statement № 1684) Standard *registration period is up to 12 months

Development of technical and operational documentation for PP 1684

Maintenance of technical tests

Support of toxicological tests

Clinical trial support

Collecting the registration dossier and submitting it to Roszdravnadzor

Popular

Medical Device Registration in the Russian Federation (Government Decree № 1684) Pro *registration period is up to 10 months

In addition to the standard package:

Revision of drawings and design documentation

Formation of the composition of a medical device according to the requirements of 44 FL and 223 FL

Medical Device Registration in the Russian Federation (Government Decree № 1684) Business *registration period is up to 8 months

In addition to the Pro package:

Collecting a complete set of dossiers for transmission to the Customer in electronic and paper form

Providing market analytics

Consulting support of the RU holder throughout the year

Manufacturer's trademark protection

Development of production processes for packaging and production of MD

Medical Device Import Registration (Government Decree № 1684) Standard *registration period is up to 12 months

Development of technical and operational documentation for PP 1684

Maintenance of technical tests

Support of toxicological tests

Clinical trial support

Collecting the registration dossier and submitting it to Roszdravnadzor

Popular

Medical Device Import Registration (Government Decree № 1684) Pro *registration period is up to 10 months

In addition to the Standard package:

Translation of documentation into Russian

Notarization of documentation

Formation of a set of products for the requirements of 44 and 223 FL

Medical Device Import Registration (Government Decree № 1684) Business *registration period is up to 8 months

In addition to the Pro package:

Consulting support of the RC holder throughout the year

Manufacturer's trademark protection

Development of production processes for packaging and production of MD

Providing a specialist to interact with a foreign manufacturer

Development of a distribution agreement (2-lingual)

Cases

Received a registration certificate

Dental burs

Risk class: 2a

Registration certificate number: РЗН 2025/25554

Registration period: 11 months

Client: IE Alekseeva

More detailed

Intubation video laryngoscope

Risk class: 2a

Registration certificate number: РЗН 2025/26293

Registration period: 10 months

Client: "Marathon" LLC

More detailed

Electrosurgical generator Bipolar Leadsure 100

Risk class: 2b

Registration certificate number: Г004-00110-00/05098331

Registration period: 13 months

Client: "Bipolar" LLC

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Disposable protective coverall

Risk class: 1

Registration certificate number: РЗН 2025/25730

Registration period: 8 months

Client: "Fabrika" LLC

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Disposable medical clothing set

Risk class: 1

Registration certificate number: РЗН 2025/25730

Registration period: 8 months

Client: IE Potekhin

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Ozonator OP1M

Risk class: 2a

Registration certificate number: РЗН 2024/22942

Registration period: 13 months

Client: "Orion-Si" LLC

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Ikeda video endoscopic system

Risk class: 2a

Registration certificate number: РЗН 2025/26151

Registration period: 7 months

Client: "Bipolar" LLC

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Leadsonic ultrasonic surgical system

Risk class: 2b

Registration certificate number: Г004-00110-00/03384622

Registration period: 10 months

Client: "Bipolar" LLC

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Rehabilitation stomatic devices

Risk class: 1

Registration certificate number: РЗН 2024/24210

Registration period: 7 months

Client: "Alkomed" LLC

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Electric stapler

Risk class: 2b

Registration certificate number: Г004-00110-00/05196642

Registration period: 14 months

Client: "Bipolar" LLC

More detailed

Team

Heads of the Medical Device Registration Department

Bityukova Svetlana Yurievna

Head of the Department of Registration of Medical Devices

Klimov Vladislav Yurievich

Executive Director

Questions

Frequently Asked Questions

The answer is that the standard registration period is 12 months. However, we can offer accelerated medical device registration packages.

The required documentation package is formed depending on the type of product and the MI risk class. A list of required documents is provided upon request.

Yes, we fully support technical, toxicological, and clinical testing.

The registration dossier is submitted remotely through the Customer's personal account of Public Services

We promptly address Roszdravnadzor’s comments, make corrections, and resubmit the documents without delays.

Advantages

What will you get?

/01

Legal entry into the Russian market

We officially launch your products into circulation, protecting them from confiscation, fines, and blocking. You gain access to government and commercial tenders.

/02

Fixed price

No hidden fees. The price includes all stages: from dossier collection and testing to obtaining a registration certificate.

/03

Your personal expert

A personal manager will accompany the project and always keep you informed.

/04

Reduce time to market by 40%

Our experts understand all the pitfalls and bureaucratic procedures. We optimize every step so you can start selling before your competitors.

/05

Reducing the risk of Roszdravnadzor refusal to a minimum

Thanks to our deep expertise in legislation and the industry, we prepare a dossier that meets all requirements the first time.

Advantages

Why us?

Expensive? It's an investment in your reputation and profits.

Fines for illegal drug trafficking can reach 5 million rubles, plus confiscation and criminal liability. Our service pays for itself with just one risk avoided.

We can do it ourselves

Save time and stress, not money. One incorrect document and the process can drag on for months. We know how to get you through the process quickly and efficiently.

There are cheaper offers

Our pricing is a turnkey package. Low prices often conceal additional fees for testing or revisions. We work honestly and transparently.

Transparency

Guarantees and trust

Payment in installments

The payment is divided into logical stages (start, submission of documents, successful tests, outcome). You control the process and pay for the results.