+7 (495) 363-15-36
+7 (962) 953-75-54
Registration from the first filing and in adherence to the regulation!
Turn-key registration
«Supporting» the registration
We share our experience!
We are on Roszdrav's website

It's a partner's gratitude that fills us with new strength, inspires us and instills confidence in achieving the result.

We thank all and everyone who appreciates our work.....

Our company has been rendering medical registration services for 16 years.  During this period, we have accumulated a large amount of knowledge and acquired exclusive skills in this area. We have worked out a number of unique tools, which help us to speed up the procedure, bring the terms closer and simplify the process of registration.  Our specialists have developed a number of techniques that allow to thoroughly study the materials and promptly prepare the documents.

Thanks to this, the procedure is transparent for the customer and the service price is stable. Our attentive experts are loyal to customers. They are going to provide you with detailed explanations of all the points concerning the specifics of the product and the registration procedure as a whole. They are inventive in non-standard situations and are capable to perform a concept-oriented job in order to hit the primary goal - obtaining the registration certificate of Federal Supervisory Agency for Health Care and Social Development (Roszdravnadzor).

  • If you know what the registration is, and you prepare the set of registration documents on your own, test and reply to notices...
  • If the registration procedure seems to you as something complicated, labor-intensive and is often conjugated with a stressful situation...
  • If you are declined again and again, if you have got a problem with the search of analogue to your medical product, and, well, you've just got no time...
  • If you are about to apply to a third-party company for services, but you do not have extra funds...

THEN, it's us whom you can fully rely on!

What do we mean?! We mean that we are ready to support you at any stage of the registration procedure: from preparing a registration dossier and working with notices till obtaining a registration certificate. You just prepare your own documents, we examine them and identify shortcomings, which you can safely remove subsequently.  With all this, we energize you with powerful consulting support, which gives you:

Speed

 

Reliability

 

Benefit

 

Everybody knows that one needs to work hard to register a medical product. This is a process, in which science and practice are mixed, and it stands for reason that only domain specialists should work in there. The only question is: how to determine whether the company, which undertakes to conduct the registration procedure for your medical product, possesses the required competence. The sad truth is that, sometimes, non-professionals set to this job, thirsting for profit and feeling no responsibility, and, for the manufacturer, this way means a loss of time, money, decrease in sales and all the beauties that come out of it.

We have repeatedly faced customers, who were emotionally devastated, embittered, exhausted - and they got reasons for this.  In such cases, the Law in our country should protect every manufacturer, who has already invested a lot of money into the development of an innovative product.  We have already a practice of legal protection of manufacturers from unfair partners.  Our forceful principled lawyer is adapted to such cases.  He masterfully achieves the intended goal, because he is assisted by a separate team of professional consultants specialized in the matters of registration of medical products.

Being together, we will get justice and will not let you be swindled!

 

Our specialists
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Oksana
Head of Expertise Assessment Department
  • - We are never satisfied with what has already been achieved: we constantly increase the scope of services, train specialists in registration of medical products...
  • - We do everything to let everyone get complex professional support.
Head of Expertise Assessment Department
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Nikita
Consulting Expert
    – Do you know?
  • 1. How will the registration pass on if your product has no comparable analogues in Russia?
  • 2. What documents should be submitted to Roszdravnadzor for classification of the products as medical products?
  • 3. What are the requirements to medical products containing medicine during the registration procedure within the Eurasian Economic Union?
Consulting Expert
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Svetlana
Expert, MA duplicate, substitution of MA
    – Have you ever asked yourself:
  • 1. Can MA of the year 2006 be amended?
  • 2. Is obtainment of a new MA required after change of the legal incorporation form?
  • 3. How to classify the type of the medical product in accordance with Order No. 4n dated 06/06/2012?
Expert, MA duplicate, substitution of MA
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Daria
Strategic Manager
  • - We are aiming at long-term cooperation, that's why all our relationships with customers are built on the basis of mutual trust and openness.
  • - Our partners always have the full access to the information of performed work, value of expenses and to results of each stage of registration of medical products.
Strategic Manager
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Nadezhda
Specialist registration of medical devices
    - 5 mistakes during registration, which infringe the regulation.... Including:
  • 1. The package of documents is being formed for a very long time
  • 2. The information about the product is not provided in full
  • 3. The classification of the product doesn't comply with regulations
Specialist registration of medical devices
News
Control of Utilization of Medical Products
23-08-2018
The Russian legislation specifies control of all processes in the area of utilization of medical products in the territory of the Russian Federation.
EEU TRANSITION PERIOD
23-08-2018
The utilization of medical products is regulated in strict compliance with regulatory documents within the Eurasian Economic Union (EEU)
Introduction of Quality Management Systems (QMS) in Production Process
28-08-2018
The number of innovative discoveries in medicine and biology increases every year. These vitally important inventions provide constant enhancement of properties and specifications of medical
We share our experience!
FIELD CONSULTATIONS
What would you like to find out before starting the registration?
  • How can several medical products be included in the same RU?
  • You have decided to manufacture medical products, but you do not know what documents are needed for commencement of production and further registration in Roszdrav?
  • You sell medical products of foreign origin?!  We advise you to hedge your bets...
We are ready
  • Attend your office, even if it is located in any region of Russia
  • Invite you for a cup of coffee, where you will ask your questions
  • Design a workshop and go abroad
TRAINING SPECIALISTS ON REGISTRATION

For the special benefit of manufacturers of medical products and their representatives, our company has developed a series of thematic events on the procedure for registration of medical products.  Thanks to the knowledge gained, a specialist of YOUR COMPANY will be able to collect the necessary package of documents without exterior help and go through the registration procedure independently. In our classes, sequentially, we will delve into all the steps of the procedure for registering medical products, beginning with the collection of initial documents and ending with the its submission to the registration authority.

+7 (962) 953-75-54
Why we?
THE ALLIANCE QUALITY
IS:
RESPONSIBILITY
We value our partners and value our reputation
RELIABILITY
Transparency and control of the procedure
SPEED
We have created unique techniques to simplify and speed up the procedure
EXPERIENCE
You just learn it,
and we already know
QUALITY
We work on the result!
QUALIFICATION
We are not afraid of complex works, because thanks to them our level is growing
Entrepreneurial spirit
Solving issues of any complexity
Reviews about us
Questions and answers
Is it possible to combine medical products with various types of medical products in one registration certificate in accordance with the Nomenclature classification of medical products according to the types approved by Order No. 4 of the Ministry of Healthcare of the Russian Federation d/d 06.06.2012?

One registration certificate can conclude medical products belonging to various types, provided that the classification features of the type of the medical product indicated depending on the purpose of the medical product are not violated, specifically:

- Application area;

- Invasiveness;

- Sterility;

- Frequency of usage (single or multiple application);

- Operating features;

- Design features.

Moreover, the registered products should have a single National product classification code (later OKP code) in accordance with the All-Russian Classification of Products OK 005–93 approved by resolution No.301 of Gosstandart of Russia dated 30.12.1993.

Is it necessary to obtain an import authorization for the registered medical products?
The import for the purpose of the official registration in accordance with order No.7n of the Ministry of Health of the Russian Federation “On Import Authorization of Medical Products for the Purpose of Official Registration in the Territory of the Russian Federation” dated 15.06.2012 is not required for the medical products registered in accordance with the established procedure in the territory of the Russian Federation.
Is it necessary to secure approval for import of the medical products with the Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor) for scientific purposes?

Scientific (research) activity is regulated by Federal Law No.127–FZ “On Science and State Scientific and Technical Policy” dated 23.08.1996.

Products designed only for the scientific research by the manufacturer are not medical and are no subject to the official registration as medical products under the provisions of Federal Law No.323–FZ “On Fundamental Healthcare Principles in the Russian Federation” dated 21.11.2011.

Consequently, the issues of the import procedure and circulation of the products for scientific research in the territory of the Russian Federation are beyond the competence of Roszdravnadzor.

Is it necessary to obtain an import permit for the medical product accessories?

In accordance with Federal Law No.323–FZ paragraph 1 Section 38 “On Fundamental Healthcare Principles in the Russian Federation” dated 21.11.2011, any tools, devices, apparatuses, equipment, materials and other products used for medical purposes exclusively or in combination with each other as well as together with the other units necessary for the use of these products for their intended purpose including special software and products aimed by the manufacturer at the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring of the human body, medical research, recovery, replacement, anatomical organization or the organism’s physiological function changes, averting or termination of pregnancy, the functional purpose of which is not implemented by pharmacological, immunological, genetic or metabolic exposure on the human body, constitute medical products.

In accordance with order No.7n of the Ministry of Healthcare of the Russian Federation “On Import Authorization of Medical Products for the Purpose of Official Registration in the Territory of the Russian Federation” dated 15.06.2012 Roszdravnadzor licenses the medical products import for the official registration purposes.

As per State Standard GOST 31508-2012 “Medical Products. Classification according to the potential risk of application. General requirements" belonging to a medical product — items that are not medical products on their own and according to their intended use applied jointly with medical products or in their structure in order to use medical products with respect to the intended use.

Hence an import authorization is not required for the medical product accessories.


Our partners
Implants for stabilisation of thoracic/lumbar spine
Orthopaedic matrasses
Lyapko's plastic masseurs
Dental mouth guards
Pregnancy control tests
Kometa 3Di software
Chamber alert system
VOLNA pressure reducing functional bed
Orthopaedic appliances
Adlens Emengensee corrective glasses
iD absorbing medical products
Tools for keyhole surgery
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