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Registration of medical devices in Roszdravnadzor
Registration of medical devices in Roszdravnadzor – is a procedure that allows the production and circulation of high-quality and safe medical devices on the Russian market.
Registration certificate for a medical device – is a document issued by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and gives the official right to manufacture or sell medical devices.
The procedure for registration of medical devices in Roszdravnadzor was approved by the Government of the Russian Federation No. 1416 of December 27, 2012.
Roszdravnadzor registration certificate form
The form of the registration certificate and the data indicated in it were approved by order of Roszdravnadzor No. 40-Order/13 dated January 16, 2013.
Content:
- What is a medical device?
- Hazard classes of medical devices;
- Documents required for registration of a medical device;
- State duty for the registration of a medical device;
- The process of registering a medical device with Roszdravnadzor;
- The advantages of working with our company;
- Cost and term of registration of a medical device with Roszdravnadzor;
- Stages of payment for services for registration of a medical device;
- Responsibility for the lack of a registration certificate.
Medical device description:
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.
The term medical device was approved on January 1, 2013, and previously such products were referred to as “medical devices” and “medical equipment”.
Hazard classes according to the degree of potential risk:
The hazard class of a medical device – is a conventional value used for a simplified classification of medical devices according to the degree of potential risk.
There are four hazard classes in total:
- Hazard class 1 – medical devices with a low degree of risk;
- Hazard class 2a – medical devices with an average degree of risk;
- Hazard class 2b – medical devices with an increased degree of risk;
- Hazard class 3 – medical devices with a high degree of risk.
A medical device can only be classified in one hazard class.
If a medical device consists of several components, and each of them has a different hazard class, then the entire medical device is assigned a hazard class according to the highest hazard class of the components.
* For an exact definition of the hazard class of a medical device, please contact us.
Documents required for registration of a medical device:
We request a minimum set of documentation to launch a project.
In the process of registering a medical device with Roszdravnadzor, our experts develop the missing documents.
- The document on the registration of the manufacturer as a legal entity (in the country of production);
- Manufacturer's conformity certificates;
- Medical device approval documents;
- Apostilled power of attorney for a representative (applicant) in the Russian Federation;
- ISO-13485 quality management certificate;
- Technical file for a medical device;
- Production flowchart (in case it is not displayed in the technical file);
- Operational documentation of a medical device: for example, instructions for use or operating instructions;
- Photos of medical device.
* In the absence of the necessary documents for a medical device, the experts of the CIRMI company will develop them during the registration process without additional payment from your side!
State duty for registration of medical devices:
- Hazard class 1 - RUB 83,000 (examination + registration certificate form);
- Hazard class 2a - RUB 115,000 (examination + registration certificate form);
- Hazard class 2b - RUB 147,000 (examination + registration certificate form);
- Hazard class 3 - RUB 195,000 (examination + registration certificate form).
The amount of the state duty for the registration of a medical device with Roszdravnadzor is established by Article 333.32.2 of the Tax Code of the Russian Federation.
Medical device registration process by our experts:
- We analyze the available technical documentation, clarify the purpose and technical characteristics of the medical device, check the analogues of already registered medical devices;
- We determine the hazard class of a medical device according to the degree of potential risk of use;
- We obtain an import permit for a medical device (for foreign manufacturers);
- We are finalizing (developing) a technical file for a medical device;
- We provide translation of design and operational documentation into Russian (if necessary);
- We check the completeness of the normative and technical documentation and form a package of documents for carrying out the necessary tests;
- We select testing laboratories (the types of tests depend on the medical device);
- We carry out tests in accredited testing laboratories (technical and toxicological);
- We form a package of documentation (prepare the primary registration dossier) and coordinate it with Roszdravnadzor;
- We issue a request and receive a referral for clinical trials;
- We conduct clinical trials in a specialized organization and get a positive decision on them;
- We provide state registration of a medical device in Roszdravnadzor;
- We send the generated package of documentation to an expert organization;
- We receive the original registration certificate and a positive decision of Roszdravnadzor (a copy of the order on the registration of a medical device);
- We send a complete set of documentation to the customer along with a registration certificate for a medical device.
We always fulfill our obligations!
All stages of work on the registration of medical devices are indicated in the contract with our company:
Please note: many mediators for registration of medical devices hide some of the stages of work, thereby misleading their clients! 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.
Look at our company in comparison with competitors:
Companies-competitors LLC "CIRMI" The work is carried out by sales managers, call specialists, lawyers, accountants and anyone else except trained employees Registration of medical devices is carried out by experts with specialized education and knowledge of a foreign language Accompanying the registration of a medical device follows a template, according to pre-prepared forms of documents, without deep penetration into the essence of the process and the device of a medical device, which often leads to refusals to register a medical device Registration of medical devices takes place taking into account the individual characteristics of the medical device, the technological process and the principle of operation. We develop missing documentation ourselves The testing ends with the transfer of the customer's contacts to the testing laboratory without further control of the testing The entire testing process is controlled by us. After the tests, if necessary, we amend the protocols for their successful adoption by Roszdravnadzor Communication with the customer is carried out during working hours and only by E-mail, which significantly extends the period of registration of a medical device Any way of communication, convenient for the customer, is welcomed. We communicate directly with the manufacturer in a foreign language The cost of work often increases due to the sudden "additional development of any documents" The exact cost of our services is known in advance, is fixed in the contract and remains unchanged until the completion of the project There is a high probability of reaching an intermediary, which will significantly increase the time and cost of work to support the registration of a medical device. "Broken phone" effect appears We work directly with state authorities. We independently modify the documentation and transfer the dossier (not by mail, but personally into the hands of the employees of Roszdravnadzor) There are no guarantees to support the registration of a medical device in Roszdravnadzor We provide a guarantee for the successful registration of a medical device. Otherwise, we return all losses.
Cost and term of registration of medical devices:
Medical devices of hazard class 1 - from 430,000 rubles;
The term for registration of a medical device is up to 6 months.
Medical devices of hazard class 2a - from 500,000 rubles;
The term for registration of a medical device is up to 7 months.
Medical devices of hazard class 2b - from 580,000 rubles;
The term for registration of a medical device is up to 9 months.
Medical devices of hazard class 3 - from 740,000 rubles;
The term for registration of a medical device is up to 12 months.
If part of the documentation for a medical device has already been prepared, and some stages of registration have been successfully completed, then the time and cost of the work are reduced. To receive a commercial offer for the registration of your medical device, please contact us!
* In addition to the registration certificate of Roszdravnadzor for a medical device, you may need a certificate of conformity.
Step-by-step payment for our services:
Registration of medical devices with Roszdravnadzor is a rather long procedure. For the convenience of distributing the budget of our customers, payment for services is made in several stages:
- 30% – after the conclusion of an contract with our company for the implementation of a project for the registration of a medical device in Roszdravnadzor;
- 30% – after the start of technical and toxicological tests of a medical device in the laboratory;
- 30% – after receiving official permission to conduct clinical trials;
- 10% – after registration of the medical device with Roszdravnadzor and receipt of the original registration certificate.
* If necessary, it is possible to agree on individual terms of payment for you.
The full price list for the provision of services by our experts is here.
The cost of work on the registration of the registration certificate of Roszdravnadzor does not include the state duty and the cost of services for conducting the necessary tests (technical, toxicological and clinical). The tests are paid by the Customer directly according to the invoices from the laboratories, and the state duty is paid according to the requisites of Roszdravnadzor. In the process of work, the experts of our company select the necessary indicators and standards for testing in accredited laboratories.
To receive a commercial offer for the registration of your medical device with an indication of the services for conducting tests, please contact us!
Responsibility for the lack of a registration certificate:
The Federal Law "On the Basics of Health Protection of Citizens in the Russian Federation" No. 323-FZ states that the use of medical devices with a valid registration certificate of Roszdravnadzor is permitted on the territory of the country.
The registration procedure for medical devices is mandatory by law, and fines for the sale of such devices without a registration certificate can amount to several million rubles. Liability, up to criminal, is provided for by Articles 6.28, 6.33 of the Administrative Code of the Russian Federation and Article 238.1 of the Criminal Code of the Russian Federation.
Since 2011, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation 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!
Working without delays
We understand the value of our clients' time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal - to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never "lose" their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI 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. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages - upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us 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:
- Application for amending the registration certificate in the form (sample);
- Current reference to the USRLE (tax site);
- A copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer);
- Number of the registration dossier;
- 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;
- 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).
- 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 "CIRMI" LLC);
- 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, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation 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!
Working without delays
We understand the value of our clients' time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal - to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never "lose" their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI 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. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages - upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us to work faster, carry out tests the first time, and develop documentation 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, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation 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!
Working without delays
We understand the value of our clients' time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal - to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never "lose" their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI 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. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages - upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us to work faster, carry out tests the first time, and develop documentation 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, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation 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!
Working without delays
We understand the value of our clients' time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal - to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never "lose" their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI 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. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages - upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us to work faster, carry out tests the first time, and develop documentation 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, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation 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!
Working without delays
We understand the value of our clients' time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal - to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never "lose" their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI 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. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages - upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us to work faster, carry out tests the first time, and develop documentation 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, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation 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!
Working without delays
We understand the value of our clients' time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal - to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never "lose" their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI 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. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages - upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us to work faster, carry out tests the first time, and develop documentation 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, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation 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!
Working without delays
We understand the value of our clients' time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal - to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never "lose" their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI 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. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages - upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us to work faster, carry out tests the first time, and develop documentation without a headache for the customer.
Additional services of the company CIRMI
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, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation 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!
Working without delays
We understand the value of our clients' time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal - to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never "lose" their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI 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. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages - upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us to work faster, carry out tests the first time, and develop documentation without a headache for the customer.
Адрес:
Nagatinskaya street 16,
Moscow, Russia
Телефоны:
+7 (495) 199-72-57
Moscow time
Время работы:
Monday - Friday
From 10 AM to 08 PM
Goszdravnadzor Company - Your Registrar of Medical Devices
The team of professionals of the Goszdravnadzor company was formed in 2011 to provide services in the preparation of permits for medical devices and equipment. We confidently tackle the challenges that arise in a rapidly changing economic situation. We are trusted by projects because they value an integrated approach to work, timely provision of services and a high degree of responsibility. Carefully studying the opinions and wishes of our customers, the Goszdravnadzor company is constantly improving.
The main thing for us is to ensure high quality of services and worthy fulfillment of our obligations, and that is why cooperation with us is simple and productive!
Feedback on the work done
CJSC Sebryakov-Cement expresses its gratitude to the CIRMI team for their exceptional organization and execution of the industrial safety expertise for the gas consumption facilities at GPU-28. Your high level of professionalism and attention to detail allowed us to complete the process swiftly and commission the facility in record time. We greatly value your expertise and look forward to continued collaboration.
V.T. Elnitsky
LLC Aton-Global expresses its sincere gratitude to your organization for the prompt and high-quality work in registering our supplied medical devices. Your team met all commitments with exceptional professionalism, ensuring a smooth process. We appreciate your dedication and wish the CIRMI team continued success and growth in all future endeavors.
V.V. Shipilin
PJSC “Kursk Hleb” sincerely thanks your company for your professionalism and effective partnership in the state registration of our food products. Working with CIRMI has been a smooth and pleasant experience, and we truly value the support you’ve provided. We look forward to continuing our successful collaboration in the future!
E.D. Filatov
On behalf of our management, we thank you for your meticulous work in developing the technical file and successfully registering our medical products. We greatly appreciate the expert opinions from FSBI “VNIIIMT” and the professional support provided. We look forward to continuing our collaboration and achieving more success together in the future!
S.E. Chudnov
We sincerely thank you for the successful boiler certification and low-pressure gas pipeline examination at AgroGreen LLC facilities. We were highly impressed with the efficiency and professionalism of your team. Your support has been invaluable, and we look forward to continuing our fruitful collaboration with CIRMI in the future.
P.V. Sidorenko
The City-Garant Association expresses its sincere gratitude to CIRMI for the outstanding services provided in obtaining the ISO-13485 quality management certificate. We highly recommend your well-organized team and are very pleased with our decision to partner with you. We look forward to further successful collaborations!
D.A. Orlov
We sincerely thank your company for the tremendous work in registering permits for our products. Your efforts have greatly reduced customs waiting times, allowing us to streamline our operations. We truly appreciate your support in every step of the process, which has been crucial to our growth and success. We look forward to continuing our partnership!
A.N. Chebanenko
Professionalism in the preparation of documentation for medical devices allowed us to gain invaluable experience and knowledge. Subsequently, this made us one of the leaders in this industry!
Request for registration of a medical device with Roszdravnadzor
Send your request in free form to our Email Info@cirmi.ru, or use the request form on the right.
We will answer you in just 30 minutes!
You can call us during working hours by multichannel phone +7 (495) 199-72-57
We work from 10 AM to 8 PM (without lunch)
* If you have not found the service you are looking for, this does not mean that we cannot help! Contact us and get the right answer to your question as quickly as possible!
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