• ПРОВЕДЕНИЕ РЕГИСТРАЦИИ МЕДИЦИНСКИХ ИЗДЕЛИЙ БЕЗ ПОСРЕДНИКОВ
  • INFO@GOSZDRAVNADZOR.RU
119270, город Москва

Хамовнический Вал, 14

+7 (495) 199-72-57

с 10:00 до 20:00

REGISTRATION OF MEDICAL DEVICES

FEEDBACK

Registration of medical devices in Roszdravnadzor

Registration of medical devices – is a procedure that allows the production and circulation of high-quality and safe medical devices on the Russian market.

Registration certificate for medical device – a document issued by the Federal Service for Supervision in the health sector (Roszdravnadzor) and gives the official right to issue or sale of medical devices.

* Russian version

Form of registration certificate of Roszdravnadzor


Federal Law "On the Principles of the protection of health of citizens in the Russian Federation» № 323-FZ, states that in the Russian Federation are allowed to use only those medical products that have a valid registration certificate Roszdravnadzor.

Since the registration procedure for medical devices is mandatory by law, the fines for the sale of such devices without a registration certificate can amount to several million rubles.

For more information on fines, see here.


Varieties of medical devices:

In accordance with GOST 31508-2012 and 38 article 323-FZ, medical devices are devices, devices and equipment that are used for medical purposes individually or in combination with each other.

For the full definition of a medical device, see here.


Hazard classes of medical devices:

Hazard class medical device - a conditional value applied to the simplified classification of medical devices according to the degree of potential risk.

  • Class 1 - medical devices with a low level of risk;
  • Class 2a - medical devices with a medium level of risk;
  • Class 2b - medical devices with a heightened level of risk;
  • Class 3 - medical devices with a high level of risk.

The medical device can have only one class of danger.

If a medical device consists of several components, and each of them has a different hazard class, then the entire (whole) medical device must be assigned a general hazard class according to the highest (maximum) hazard class of the components.

To accurately determine the hazard class of a medical device, you can use our table.


Documents required for registration of a medical device:

  • Documents on the registration of the manufacturer as a legal entity (in the country of production);
  • Manufacturer's certificates of conformity (if any);
  • Permits for a medical device (if any);
  • Apostilled power of attorney for a representative (applicant) in the Russian Federation;
  • Documents confirming the proper production conditions;
  • Technical file (if available);
  • Operational documentation of a medical device: for example, instruction or operation manual (if any);
  • Photos of a medical device.

In the absence of the necessary documents, our experts will develop them without additional fees.


Stages of registration of medical devices by Goszdravnadzor:

  1. We analyze the provided technical documentation, clarify the purpose and technical characteristics of the medical device, check the analogues of the registered medical devices;
  2. We obtain permission to import into the Russian Federation for a medical device (for a foreign manufacturer);
  3. We modifying (or developing) a technical file for a medical device;
  4. We translate design and operational documentation of a medical device into Russian (if necessary);
  5. We check the completeness of the regulatory and technical documentation and form a package of documents for testing;
  6. We select the optimal testing laboratories (the types and types of tests depend on the registered medical device);
  7. We carry out tests in an accredited testing laboratory (if necessary, we make changes to the test reports);
  8. We form and sew a package of documentation (prepare the initial registration dossier), then agree on it when submitting it to Roszdravnadzor;
  9. We draw up and receive a referral for conducting clinical trials;
  10. We conduct clinical trials in a specialized organization, after which we receive a positive decision on these trials;
  11. We carry out the procedure for state registration of a medical device;
  12. We send the generated documentation to the expert organization under Roszdravnadzor;
  13. We receive the original of the Registration Certificate and the positive decision of Roszdravnadzor (a copy of the registration order);
  14. We transfer a complete set of documentation to the customer along with a registration certificate for a medical device..

Goszdravnadzor Company fulfills its obligations!

We indicate all stages of work on registration of a medical device in the contract:

Please note: most mediators for registration of medical devices hide some of the stages of work, thereby misleading their customers!

There are many cases when unscrupulous "registrars" entered into a contract for the provision of services, and then brought the final cost of work to disproportionately high figures.

In this article, you will learn more about how to choose a medical device registrar.


State duty for registration of medical devices:

  • Hazard class 1 - 45,000 rubles (examination) + 7,000 rubles (form RC);
  • Hazard class 2a - 65,000 rubles (examination) + 7,000 rubles (form RC);
  • Hazard class 2b - 85,000 rubles (examination) + 7,000 rubles (form RC);
  • Hazard class 3 - 115,000 rubles (examination) + 7,000 rubles (form RC).

The size of the state fee established by Article 333.32f.2 Tax Code.


In addition to the registration certificate of Roszdravnadzor, you may need a certificate or declaration of conformity.


The cost and term of registration of medical devices:

  • Medical devices of hazard class 1 – 420,000 rubles ($, , ¥);

The project will be completed within 6 months.

  • Medical devices of hazard class 2a – 510,000 rubles ($, , ¥);

The project will be completed within 7 months.

  • Medical devices of hazard class 2b – 580,000 rubles ($, , ¥);

The project will be completed within 9 months.

  • Medical devices of hazard class 3 – 690,000 rubles ($, , ¥);

The project will be completed within 12 months.

If you have already prepared a part of the documentation and some of the registration stages have already been completed, the terms and cost of the work are reduced.


Full price list for services by our experts here.


The cost of the registration certificate issued by Roszdravnadzor does not include the state duty and the cost of conducting the necessary tests (technical, toxicological and clinical). The tests are paid by the Customer directly against the invoices in the laboratory, and the state fee is paid by the invoice from Roszdravnadzor.

In the process, we select parameters for tests with accredited test laboratories.


Since 2011, the company Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction to the smallest nuances. And today we confidently declare that we are one of the leaders in the design and development of permits for medical devices!


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company is an organism united by a common goal - to do the work so that the client is satisfied, turns to us again, and advises colleagues and friends. An optimally selected staff of employees successfully solves any tasks in the implementation of projects, moreover, they do it without involving other performers. Our client will never "lose" his project manager since we do not have a staff turnover.

In words, in a contract and in work

The obvious superiority of the Goszdravnadzor company over its competitors is transparent and honest interaction with the customer. After receiving a commercial offer, you can be sure that the prices and terms for the provision of services in it are final. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages - upon completion of the work.

Successful registration guarantee

By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for a medical device. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and shorten the time it takes to complete the work.

Experience, knowledge and authority.

Since 2011, Goszdravnadzor has been implementing projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, carry out tests the first time, and develop documentation without a headache for the customer.

Amendments to the registration certificate of Roszdravnadzor

Amending a registration certificate is a procedure that involves changing any data in a previously issued registration certificate for a medical device.


Grounds for amendments to the certificate of registration:

  • Change of information concerning the applicant of the marketing authorization:
    • Change of legal entity;
    • Change of the name of the legal entity (full or abbreviated)
    • Change of address (location) of a legal entity;
    • Change of surname or first name; address of the place of residence of the individual entrepreneur, and the details of the document proving his identity.
  • Change of the address of production of a medical device;
  • Change of the brand name of a medical device;
  • Specifying the type of medical product according to the nomenclature Classification of medical devices (in his absence).

Documentation required to amend the registration certificate of Roszdravnadzor:

  1. Application for amending the registration certificate in the form (sample);
  2. Current reference to the USRLE (tax site);
  3. A copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer);
  4. Number of the registration dossier;
  5. In case of changes in the information about the applicant, as well as the place of manufacture of the medical device - documents confirming such changes;
  6. In the event of a change in the name of a medical device: information about the regulatory documentation for the medical device, technical documentation of the manufacturer (manufacturer) for the medical device, brought in line with the new name of the medical device; manufacturer's (manufacturer's) operational documentation for a medical device, including instructions for use or operating instructions for a medical device, brought in line with the new name of the medical device; photographic images of a general view of a medical device along with accessories necessary for the intended use of the medical device (at least 18 × 24 centimeters in size).
  7. List of documents (sample).

Please note that the above list is exemplary, and is not regulated by specific instruments, and presented solely for the purpose of explanation of what documents may be taken into consideration. A complete list of documents is determined individually for each procedure, amendments to the registration certificate!


The main stages of amending the registration certificate of Roszdravnadzor:

  • Drawing up an application and an inventory on amending the registration certificate;
  • Collection, analysis, revision, and, if necessary, translation of all necessary documentation (translators work at Goszdravnadzor);
  • Sending official requests with further receipt of a letter from the manufacturer confirming that changes in the registration certificate do not entail changes in properties and characteristics that affect the quality, effectiveness and safety of a medical device;
  • Payment of state fees;
  • Submission of the collected package of documents together with a receipt for payment of the state fee to Roszdravnadzor;
  • Accompanying the process of making changes to the registration certificate and obtaining the original document;
  • Transfer of a set of documents together with new documentation to the customer.

Experts who are ready to solve your problem:

    • Project manager for work with clients and his assistant,
    • Specialist in the development of documentation and his assistant,
    • Translators,
    • Testing expert (technical, toxicological and clinical trials),
    • Courier.

Here you can see the full price list for our services.


Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal - to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages - upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.

Changes to registration documents (dossier)

The procedure for making changes to registration documents is carried out if it is necessary to make changes to the set of registration documents and if the changes made do not relate to the information specified on the registration certificate form.

The procedure for making changes to registration documents is carried out if it is necessary to make changes to the set of registration documents and if the changes made do not relate to the information specified on the registration certificate form.

The need to make changes can arise for a variety of reasons. It should be remembered that this procedure is official and all the features of its implementation are reflected in the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416.


Expertise when making changes to registration documents:

If it is necessary to make changes to the technical and operational documentation, the changes are made based on the results of an examination carried out in a manner similar to the procedure for conducting an examination of the quality, effectiveness and safety of a medical device for its state registration in accordance with clause 21 of the Rules.

In accordance with Article 333.32.2 of the Tax Code of the Russian Federation for hosting the quality of the examination, the effectiveness and safety of a medical device (depending on the potential risk of a class of its application) when amending the documents contained in the registration dossier of medical products state fee shall be paid in the following amounts:

  • Hazard class 1 - 20,000 rubles;
  • Hazard class 2a - 30,000 rubles;
  • Hazard class 2b - 40,000 rubles;
  • Hazard class 3 - 55,000 rubles.

For making changes to the documents contained in the registration dossier of a medical device that do not require an examination of the quality, effectiveness and safety of a medical device, the state fee is 1,500 rubles.


Process for making changes to registration documents:

  • Preparing official statement (prepared in accordance administrative regulations) in Roszdravnadzor to amend the registration documents or registration dossier;
  • Payment of state fees in accordance with the tariff;
  • Necessary tests: technical, toxicological, clinical
  • Submission of the collected documentation package together with a receipt for payment of the state fee to Roszdravnadzor.
  • Sending clarifying requests to Roszdravnadzor
  • Maintenance of the procedure for making changes to registration documents (dossier)
  • Obtaining an order to amend registration documents (dossier)
  • Transfer of a new set of documentation to the customer (applicant).

Experts who are ready to solve your problem:

  • Project manager for work with clients and his assistant,
  • Specialist in the development of documentation and his assistant,
  • Translators,
  • Testing expert (technical, toxicological and clinical trials),
  • Courier.

Here you can see the full price list for our services.


Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal - to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages - upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.

Obtaining a duplicate of the registration certificate of Roszdravnadzor

In case of loss of the original registration certificate of Roszdravnadzor, or its damage, you can get a duplicate of it by contacting our company.


Reasons to obtain a duplicate of the registration certificate:

  • Loss of registration certificate for a medical device (equipment).
  • Damage to the registration certificate for a medical device (equipment).

Documentation required to obtain a duplicate of the registration certificate:

  • Application for the issue of a duplicate of the registration certificate of Roszdravnadzor (sample);
  • In case of damage to the registration certificate, the damaged registration certificate is attached to the application for a duplicate.

Experts who are ready to solve your problem:

  • Project manager for work with clients and his assistant,
  • Specialist in the development of documentation and his assistant,
  • Translators,
  • Testing expert (technical, toxicological and clinical trials),
  • Courier.

Here you can see the full price list for our services.


Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal - to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages - upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.

Clinical trials of medical devices

Clinical trials (or clinical research) of medical devices is a procedure for confirming the quality and safety of medical devices in accordance with clinical indicators and standards approved and agreed with the testing laboratory.

Clinical trials are carried out by medical organizations approved by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and the Federal Service for Accreditation (Rusaccreditation).
There are two types of clinical trials of medical devices: in the form of analogy with other medical devices and in the form of actual trials to assess their safety and effectiveness, including with human participation. In the latter version, tests are carried out in relation to a new type of medical device, the use of new complex or unique methods of prevention, diagnosis, treatment of diseases, as well as new complex medical technologies; and are also carried out if the efficacy and safety of the medical device was not confirmed during the first form of research.

What is needed for a successful clinical trials:

  • A sample of the medical device;
  • Permission to conduct clinical trials issued by Roszdravnadzor (we will help with obtaining);
  • Test reports from other testing laboratories (if any);
  • Conclusions of toxicological studies of a medical device (we will help with obtaining);
  • Technical documentation for a medical device (we will help with development);
  • User manual for a medical device (we will help with development);
  • Photos of the medical device.

Experts who are ready to solve your problem:

  • Project manager for work with clients and his assistant,
  • Specialist in the development of documentation and his assistant,
  • Translators,
  • Testing expert (technical, toxicological and clinical trials),
  • Courier.

Here you can see the full price list for our services.


Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal - to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages - upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.

Toxicological testing of medical devices

Toxicological testing of medical devices is a procedure for confirming the quality and safety of medical devices in accordance with the toxicological indicators and standards approved and agreed with the testing laboratory.

For all medical devices that come into contact with the human body during their use, toxicological tests are prescribed.


Toxicology is based on the determination of the level of impact on the human body and includes the verification of physical and chemical, sanitary and chemical, biological indicators, including biological indicators in vitro and in vivo.


Medical devices intended for contact with the human body:

  • Medical devices in contact with the human surface (skin);
  • Medical devices temporarily introduced into the human body;
  • Medical devices intended for implantation into the human body.

On average, toxicological tests are carried out no longer than twenty working days, however, if additional tests are required, this period can be increased with the consent of the customer.


Experts who are ready to solve your problem:

  • Project manager for work with clients and his assistant,
  • Specialist in the development of documentation and his assistant,
  • Translators,
  • Testing expert (technical, toxicological and clinical trials),
  • Courier.

Here you can see the full price list for our services.


Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal - to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages - upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.

Technical testing of medical devices

Technical testing of medical devices is a procedure for confirming the quality and safety of medical devices in accordance with the technical indicators and standards approved and agreed with the testing laboratory.

There are two formats of technical tests for registration of the registration certificate of Roszdravnadzor: in the form of assessing the quality of medical devices or in the form of real tests in the laboratory.

  • The first form is carried out in the relations of products, for the commissioning or installation of which a special permit is required, or for the creation of conditions or the construction of individual capital structures, that is, an analysis is made based on the documentation provided by the manufacturer. If the analysis, assessment of the submitted documentation does not allow us to speak unambiguously about the quality and safety of a medical device, then real tests are carried out in a testing laboratory.
  • For all other medical devices, the second option is used - carrying out real tests in the laboratory.

The procedure for conducting technical tests of medical devices is given in the order of the Ministry of Health of the Russian Federation dated January 9, 2014 No. 2n. The link to download the document is here.


Our customers can independently choose for themselves a testing laboratory that carries out technical tests of medical devices, and at the same time, we also offer to use our own testing laboratory, in which the testing time is minimal, and the probability of successful testing is as high as possible.


Here you can see the full price list for our services.


Experts who are ready to solve your problem:

  • Project manager for work with clients and his assistant,
  • Specialist in the development of documentation and his assistant,
  • Translators,
  • Testing expert (technical, toxicological and clinical trials),
  • Courier.

Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal - to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages - upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.

Additional services of the company Goszdravnadzor

Together with the main list of services related to interaction with Roszdravnadzor, we also offer the following services:

  • We develop documentation for the registration of a medical device in Roszdravnadzor;
  • We advise on the registration of medical devices;
  • We carry out a full and partial audit of design and operational documentation for medical devices;
  • We fix the "mistakes" of other certification centers and authorities;
  • We issue an official permit for the import of medical devices through the Russian customs;
  • We send clarifying (explanatory) requests to Roszdravnadzor;
  • We select the type of nomenclature classifier for medical devices;
  • We carry out all kinds of tests of medical devices;
  • We issue trademarks for medical devices;
  • We represent the interests of foreign organizations on the territory of the Russian Federation (we provide a legal entity-applicant).

Experts who are ready to solve your problem:

  • Project manager for work with clients and his assistant,
  • Specialist in the development of documentation and his assistant,
  • Translators,
  • Testing expert (technical, toxicological and clinical trials),
  • Courier.

Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal - to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages - upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.

Адрес:

Russia, Moscow, Khamovnichesky Val 14

Телефон:

+7 (495) 199-72-57 multichannel

Время работы:

From 9:00 am to 19:00 pm Sunday - closed

Goszdravnadzor - Chief Registrar of Medical Devices

Awesome Image Awesome Image Awesome Image Awesome Image Awesome Image Awesome Image Awesome Image Awesome Image Awesome Image

Goszdravnadzor was formed in 2011, and, at present, it confidently solves the problems of manufacturers and suppliers of medical products that arise in a rapidly changing economic situation. They trust us because they value an integrated approach to work, high-quality and timely implementation of projects, professionalism and a high degree of responsibility.

It is also important for us how the result is achieved. By carefully studying the opinions and wishes of our clients, Goszdravnadzor is constantly growing and improving. We strive to make cooperation with us simple and productive, without changing the basic principles of our activity: an individual approach to each customer, providing high quality services and worthy fulfillment of our obligations.

Feedback on the work done from Russian companies:

Professionalism in the registration of medical devices allowed us to gain invaluable experience and knowledge. Subsequently, this made us one of the leaders in this industry!

Online request for registration of a medical device in Roszdravnadzor

Send your request in free form to our mail INFO@GOSZDRAVNADZOR.RU, or use the request form on the right.

We will give you an answer in 30 minutes!

You can call us during working hours on the multichannel phone 8 (495) 199-72-57

We work from 9 am to 7 pm (without lunch)

* If you did not find the service you want, it does not mean that we can not help! Please contact us and get the right answer to your question as quickly as possible!

    Нажмите на флаг.

    Stay up to date with useful news (No spam)