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Medical product registration
Registration of medical devices with the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) is a state procedure aimed at obtaining permission to sell quality and safe medical devices on the Russian market. It involves checking the compliance of medical devices with the requirements of state standards and regulations in the field of health care.
According to the Federal law № 323-FZ " About the bases of citizens' health protection", only those medical devices that have a valid registration certificate of Roszdravnadzor are allowed to use on the territory of Russian Federation. This guarantees the safety and quality of medical devices that are used in medical institutions and providing medical services to citizens.
In addition, the registration procedure for medical devices also includes verification of compliance of packaging, labeling and instructions for use. This is necessary in order to ensure that consumers are informed and safe when using medical devices.
So, the registration procedure of medical devices with Roszdravnadzor plays an important role in ensuring quality and safe healthcare in the Russian Federation, as well as protecting the interests of consumers of medical devices and their manufacturers.
According to the Federal law № 323-FZ " About the bases of citizens' health protection", only those medical devices that have a valid registration certificate of Roszdravnadzor are allowed to use on the territory of Russian Federation. This guarantees the safety and quality of medical devices that are used in medical institutions and providing medical services to citizens.
In addition, the registration procedure for medical devices also includes verification of compliance of packaging, labeling and instructions for use. This is necessary in order to ensure that consumers are informed and safe when using medical devices.
So, the registration procedure of medical devices with Roszdravnadzor plays an important role in ensuring quality and safe healthcare in the Russian Federation, as well as protecting the interests of consumers of medical devices and their manufacturers.
Medical product registration
Registration of medical devices with the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor)
is a state procedure aimed at obtaining permission to sell quality and safe medical devices on the Russian market. It involves checking the compliance of medical devices with the requirements of state standards and regulations in the field of health care.
According to the Federal law № 323-FZ " About the bases of citizens' health protection", only those medical devices that have a valid registration certificate of Roszdravnadzor are allowed to use on the territory of Russian Federation. This guarantees the safety and quality of medical devices that are used in medical institutions and providing medical services to citizens.
In addition, the registration procedure for medical devices also includes verification of compliance of packaging, labeling and instructions for use. This is necessary in order to ensure that consumers are informed and safe when using medical devices.
So, the registration procedure of medical devices with Roszdravnadzor plays an important role in ensuring quality and safe healthcare in the Russian Federation, as well as protecting the interests of consumers of medical devices and their manufacturers.
is a state procedure aimed at obtaining permission to sell quality and safe medical devices on the Russian market. It involves checking the compliance of medical devices with the requirements of state standards and regulations in the field of health care.
According to the Federal law № 323-FZ " About the bases of citizens' health protection", only those medical devices that have a valid registration certificate of Roszdravnadzor are allowed to use on the territory of Russian Federation. This guarantees the safety and quality of medical devices that are used in medical institutions and providing medical services to citizens.
In addition, the registration procedure for medical devices also includes verification of compliance of packaging, labeling and instructions for use. This is necessary in order to ensure that consumers are informed and safe when using medical devices.
So, the registration procedure of medical devices with Roszdravnadzor plays an important role in ensuring quality and safe healthcare in the Russian Federation, as well as protecting the interests of consumers of medical devices and their manufacturers.
Medical product registration under the EEU
The rules for registering medical devices under EAEU law were approved by Decision No. 46 of the Council of the Eurasian Economic Commission (EEC) of February 12, 2016. These rules provide for a transition period until December 31, 2021, during which registration of medical devices can be carried out in accordance with the rules of the Eurasian Economic Union (EAEU) or the national legislation of participating countries. Starting from 2022, all medical devices will be registered according to the EAEU rules.
To register a medical product, the applicant chooses a reference state - a member state of the Eurasian Economic Union whose authorized body carries out the registration of the medical product. Then the applicant applies to the states of recognition-member states of the Eurasian Economic Union, to the authorized bodies of which the expert opinion of the reference state is provided. Currently, the EAEU includes the following member states: Russian Federation, Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Republic of Kyrgyzstan.
The stages of registration of medical products under the EAEU rules are as follows:
To register a medical product, the applicant chooses a reference state - a member state of the Eurasian Economic Union whose authorized body carries out the registration of the medical product. Then the applicant applies to the states of recognition-member states of the Eurasian Economic Union, to the authorized bodies of which the expert opinion of the reference state is provided. Currently, the EAEU includes the following member states: Russian Federation, Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Republic of Kyrgyzstan.
The stages of registration of medical products under the EAEU rules are as follows:
- The manufacturer brings the documentation in accordance with the requirements of the EAEU.
- Passes the necessary tests.
- Collects the registration dossier and submits it to Roszdravnadzor for completeness and accuracy check.
- The Federal Service for the Supervision of Health Care and Social Development conducts an expert examination, checks the quality, safety and effectiveness of the medical product.
- Depending on the class of the medical product, in parallel with the examination, a commission may go to the production site to assess the compliance of the quality management system with the mandatory requirements of the EAEU (EEC Council Decision No. 106 of 10.11.17).
- If Federal Service for Supervision in Healthcare and Social Development (Roszdravnadzor) issues a positive conclusion of the expert examination and the production inspection is successful, the applicant pays the state fees of the countries of recognition (those countries where the medical device is planned to be sold). After that, the documents are sent on to the authorized bodies of the countries of recognition.
- The countries of recognition agree (or do not agree) on the results of the expertise.
- The manufacturer receives the registration certificate of the EAEU. It is valid in Russia and in the countries of recognition, which have agreed on the documents.
Medical product registration under the EEU
The rules for registering medical devices under EAEU law were approved by Decision No. 46 of the Council of the Eurasian Economic Commission (EEC) of February 12, 2016. These rules provide for a transition period until December 31, 2021, during which registration of medical devices can be carried out in accordance with the rules of the Eurasian Economic Union (EAEU) or the national legislation of participating countries. Starting from 2022, all medical devices will be registered according to the EAEU rules.
To register a medical product, the applicant chooses a reference state - a member state of the Eurasian Economic Union whose authorized body carries out the registration of the medical product. Then the applicant applies to the states of recognition-member states of the Eurasian Economic Union, to the authorized bodies of which the expert opinion of the reference state is provided. Currently, the EAEU includes the following member states: Russian Federation, Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Republic of Kyrgyzstan.
The stages of registration of medical products under the EAEU rules are as follows:
To register a medical product, the applicant chooses a reference state - a member state of the Eurasian Economic Union whose authorized body carries out the registration of the medical product. Then the applicant applies to the states of recognition-member states of the Eurasian Economic Union, to the authorized bodies of which the expert opinion of the reference state is provided. Currently, the EAEU includes the following member states: Russian Federation, Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Republic of Kyrgyzstan.
The stages of registration of medical products under the EAEU rules are as follows:
- The manufacturer brings the documentation in accordance with the requirements of the EAEU.
- Passes the necessary tests.
- Collects the registration dossier and submits it to Roszdravnadzor for completeness and accuracy check.
- The Federal Service for the Supervision of Health Care and Social Development conducts an expert examination, checks the quality, safety and effectiveness of the medical product.
- Depending on the class of the medical product, in parallel with the examination, a commission may go to the production site to assess the compliance of the quality management system with the mandatory requirements of the EAEU (EEC Council Decision No. 106 of 10.11.17).
- If Federal Service for Supervision in Healthcare and Social Development (Roszdravnadzor) issues a positive conclusion of the expert examination and the production inspection is successful, the applicant pays the state fees of the countries of recognition (those countries where the medical device is planned to be sold). After that, the documents are sent on to the authorized bodies of the countries of recognition.
- The countries of recognition agree (or do not agree) on the results of the expertise.
- The manufacturer receives the registration certificate of the EAEU. It is valid in Russia and in the countries of recognition, which have agreed on the documents.
Medicines registration
The State Registration of medications is an important process that is carried out to ensure the safety and effectiveness of medications. This process includes the expert examination of medicines, as well as the evaluation of their documentation. After passing all the necessary procedures, the medicinal product receives state registration, which allows it to be put into circulation on the territory of the Russian Federation.
State registration is subject to:
Orphan drugs (designed to treat rare diseases) often require longer and more expensive research than conventional drugs, because rare diseases are more difficult to diagnose and study. However, such drugs can significantly improve the quality of life of patients suffering from rare diseases and may be the only form of treatment available to these people.
Therefore, state registration of medicines is an important step in the life cycle of medicines that ensures their safety and efficacy when used by patients.
State registration is subject to:
- All drugs that are to be put into circulation in the Russian Federation for the first time. This includes both new drugs and existing drugs that have not been previously registered in Russia.
- Drugs that were previously registered but produced in other dosage forms, for example, in a new dosage form when its clinical relevance and effectiveness is proven. This means that if the manufacturer decides to change the dosage form, it will have to go through the state registration process all over again.
- New combinations of previously registered drugs. Such combinations can be created to increase the effectiveness of a drug or to facilitate its use.
Orphan drugs (designed to treat rare diseases) often require longer and more expensive research than conventional drugs, because rare diseases are more difficult to diagnose and study. However, such drugs can significantly improve the quality of life of patients suffering from rare diseases and may be the only form of treatment available to these people.
Therefore, state registration of medicines is an important step in the life cycle of medicines that ensures their safety and efficacy when used by patients.
Medicines registration
The State Registration of medications is an important process that is carried out to ensure the safety and effectiveness of medications. This process includes the expert examination of medicines, as well as the evaluation of their documentation. After passing all the necessary procedures, the medicinal product receives state registration, which allows it to be put into circulation on the territory of the Russian Federation.
State registration is subject to:
Orphan drugs (designed to treat rare diseases) often require longer and more expensive research than conventional drugs, because rare diseases are more difficult to diagnose and study. However, such drugs can significantly improve the quality of life of patients suffering from rare diseases and may be the only form of treatment available to these people.
Therefore, state registration of medicines is an important step in the life cycle of medicines that ensures their safety and efficacy when used by patients.
State registration is subject to:
- All drugs that are to be put into circulation in the Russian Federation for the first time. This includes both new drugs and existing drugs that have not been previously registered in Russia.
- Drugs that were previously registered but produced in other dosage forms, for example, in a new dosage form when its clinical relevance and effectiveness is proven. This means that if the manufacturer decides to change the dosage form, it will have to go through the state registration process all over again.
- New combinations of previously registered drugs. Such combinations can be created to increase the effectiveness of a drug or to facilitate its use.
Orphan drugs (designed to treat rare diseases) often require longer and more expensive research than conventional drugs, because rare diseases are more difficult to diagnose and study. However, such drugs can significantly improve the quality of life of patients suffering from rare diseases and may be the only form of treatment available to these people.
Therefore, state registration of medicines is an important step in the life cycle of medicines that ensures their safety and efficacy when used by patients.
Dietary supplements registration
Registration of dietary supplements in Russia is an important and mandatory process that guarantees the quality and safety of the product. All supplements that successfully pass registration receive a Certificate of State Registration.
The procedure for registering dietary supplements in Russia includes three stages:
The registration process begins with the submission of an application to the Federal Service for Supervision in the Sphere of Healthcare and Social Development of the Russian Federation (Roszdravnadzor). The application must contain information about the applicant company, the product, its composition and principles of action, as well as the planned dosages and recommended methods of use.
Once the application is submitted, the examination of product samples begins. The expertise includes an assessment of the quality, safety and efficacy of the product. For this purpose, physicochemical and microbiological studies are conducted, as well as studies to determine the active substances and their dosage.
In addition to the examination of product samples, the documentation attached to the application is analyzed. This may include data on production and quality control, the results of clinical trials, etc.
After all stages of registration have been completed and a positive decision by the experts, a Certificate of State Registration is issued, which confirms the right to sell the dietary supplements on the territory of Russia.
The procedure for registering dietary supplements in Russia includes three stages:
- Performing an examination of the product samples provided for research.
- Analysis of the documentation attached to the application.
- Formalization of the Certificate of State Registration (SRC).
The registration process begins with the submission of an application to the Federal Service for Supervision in the Sphere of Healthcare and Social Development of the Russian Federation (Roszdravnadzor). The application must contain information about the applicant company, the product, its composition and principles of action, as well as the planned dosages and recommended methods of use.
Once the application is submitted, the examination of product samples begins. The expertise includes an assessment of the quality, safety and efficacy of the product. For this purpose, physicochemical and microbiological studies are conducted, as well as studies to determine the active substances and their dosage.
In addition to the examination of product samples, the documentation attached to the application is analyzed. This may include data on production and quality control, the results of clinical trials, etc.
After all stages of registration have been completed and a positive decision by the experts, a Certificate of State Registration is issued, which confirms the right to sell the dietary supplements on the territory of Russia.
Dietary supplements registration
Registration of dietary supplements in Russia is an important and mandatory process that guarantees the quality and safety of the product. All supplements that successfully pass registration receive a Certificate of State Registration.
The procedure for registering dietary supplements in Russia includes three stages:
The registration process begins with the submission of an application to the Federal Service for Supervision in the Sphere of Healthcare and Social Development of the Russian Federation (Roszdravnadzor). The application must contain information about the applicant company, the product, its composition and principles of action, as well as the planned dosages and recommended methods of use.
Once the application is submitted, the examination of product samples begins. The expertise includes an assessment of the quality, safety and efficacy of the product. For this purpose, physicochemical and microbiological studies are conducted, as well as studies to determine the active substances and their dosage.
In addition to the examination of product samples, the documentation attached to the application is analyzed. This may include data on production and quality control, the results of clinical trials, etc.
After all stages of registration have been completed and a positive decision by the experts, a Certificate of State Registration is issued, which confirms the right to sell the dietary supplements on the territory of Russia.
The procedure for registering dietary supplements in Russia includes three stages:
- Performing an examination of the product samples provided for research.
- Analysis of the documentation attached to the application.
- Formalization of the Certificate of State Registration (SRC).
The registration process begins with the submission of an application to the Federal Service for Supervision in the Sphere of Healthcare and Social Development of the Russian Federation (Roszdravnadzor). The application must contain information about the applicant company, the product, its composition and principles of action, as well as the planned dosages and recommended methods of use.
Once the application is submitted, the examination of product samples begins. The expertise includes an assessment of the quality, safety and efficacy of the product. For this purpose, physicochemical and microbiological studies are conducted, as well as studies to determine the active substances and their dosage.
In addition to the examination of product samples, the documentation attached to the application is analyzed. This may include data on production and quality control, the results of clinical trials, etc.
After all stages of registration have been completed and a positive decision by the experts, a Certificate of State Registration is issued, which confirms the right to sell the dietary supplements on the territory of Russia.
Medical outsourcing
Outsourcing in healthcare is a process that involves the transfer of certain functions and services of medical institutions to outside organizations or specialists. It allows you to reduce costs and increase the efficiency of a medical institution.
Among the services that can be outsourced are the following:
Outsourcing can also include consulting and healthcare expertise. This can be useful for medical facilities that need to independently evaluate their operations and implement new technologies and treatments.
The benefits of outsourcing in health care are that it allows health care facilities to reduce personnel and equipment costs and improve the quality of services. It also accelerates the adoption of new technologies and treatments, which can lead to improved patient health and higher levels of customer satisfaction.
Among the services that can be outsourced are the following:
- Accounting and tax reporting
- Marketing research and development of marketing strategy
- Human resource management and HR services
- Introduction and support of IT solutions
- Analysis and quality control of medical services
- Logistics and inventory management
- Financial management and financial planning
Outsourcing can also include consulting and healthcare expertise. This can be useful for medical facilities that need to independently evaluate their operations and implement new technologies and treatments.
The benefits of outsourcing in health care are that it allows health care facilities to reduce personnel and equipment costs and improve the quality of services. It also accelerates the adoption of new technologies and treatments, which can lead to improved patient health and higher levels of customer satisfaction.
Medical outsourcing
Outsourcing in healthcare is a process that involves the transfer of certain functions and services of medical institutions to outside organizations or specialists. It allows you to reduce costs and increase the efficiency of a medical institution.
Among the services that can be outsourced are the following:
Outsourcing can also include consulting and healthcare expertise. This can be useful for medical facilities that need to independently evaluate their operations and implement new technologies and treatments.
The benefits of outsourcing in health care are that it allows health care facilities to reduce personnel and equipment costs and improve the quality of services. It also accelerates the adoption of new technologies and treatments, which can lead to improved patient health and higher levels of customer satisfaction.
Among the services that can be outsourced are the following:
- Accounting and tax reporting
- Marketing research and development of marketing strategy
- Human resource management and HR services
- Introduction and support of IT solutions
- Analysis and quality control of medical services
- Logistics and inventory management
- Financial management and financial planning
Outsourcing can also include consulting and healthcare expertise. This can be useful for medical facilities that need to independently evaluate their operations and implement new technologies and treatments.
The benefits of outsourcing in health care are that it allows health care facilities to reduce personnel and equipment costs and improve the quality of services. It also accelerates the adoption of new technologies and treatments, which can lead to improved patient health and higher levels of customer satisfaction.
Equipping medical organizations
Equipping a medical organization is one of the key factors in ensuring the successful operation and quality delivery of medical services. In this regard, the service of equipping medical institutions can be provided in different formats:
Complex approach to equip medical institutions allows the customer to be sure that all aspects will be taken into account and executed professionally. This includes the selection of equipment that takes into account all quality and safety requirements, as well as budgetary constraints. At the same time, the main principle is to match the equipment to the needs of a particular medical organization and maximize its effectiveness in operation.
- Project creation and complex selection of equipment "on turnkey".
- Separate service for equipping of a medical organization or a cabinet
Complex approach to equip medical institutions allows the customer to be sure that all aspects will be taken into account and executed professionally. This includes the selection of equipment that takes into account all quality and safety requirements, as well as budgetary constraints. At the same time, the main principle is to match the equipment to the needs of a particular medical organization and maximize its effectiveness in operation.
Equipping medical organizations
Equipping a medical organization is one of the key factors in ensuring the successful operation and quality delivery of medical services. In this regard, the service of equipping medical institutions can be provided in different formats:
Complex approach to equip medical institutions allows the customer to be sure that all aspects will be taken into account and executed professionally. This includes the selection of equipment that takes into account all quality and safety requirements, as well as budgetary constraints. At the same time, the main principle is to match the equipment to the needs of a particular medical organization and maximize its effectiveness in operation.
- Project creation and complex selection of equipment "on turnkey".
- Separate service for equipping of a medical organization or a cabinet
Complex approach to equip medical institutions allows the customer to be sure that all aspects will be taken into account and executed professionally. This includes the selection of equipment that takes into account all quality and safety requirements, as well as budgetary constraints. At the same time, the main principle is to match the equipment to the needs of a particular medical organization and maximize its effectiveness in operation.
Additional services
We prepare and lead the project, and the work is done by our proven partners. More time and higher quality
Occupational Safety and Health, medical examinations
Medical support is an important part of ensuring the health and safety of employees of the organization. Our company provides a wide range of services for medical support, which includes not only medical examinations, certificates and medical commissions, but also consultations on occupational safety and health.
We guarantee reliability, quality and safety in the course of our work.
- We are ready to provide turnkey assistance to your organization. Understanding that it is important for each organization to have an individual approach and take into account the specifics of its activities, our services are always adapted to the needs of each client.
- We also provide medical support services to individual clients who need personalized care.
We guarantee reliability, quality and safety in the course of our work.
Occupational Safety and Health, medical examinations
Medical support is an important part of ensuring the health and safety of employees of the organization. Our company provides a wide range of services for medical support, which includes not only medical examinations, certificates and medical commissions, but also consultations on occupational safety and health.
We guarantee reliability, quality and safety in the course of our work.
- We are ready to provide turnkey assistance to your organization. Understanding that it is important for each organization to have an individual approach and take into account the specifics of its activities, our services are always adapted to the needs of each client.
- We also provide medical support services to individual clients who need personalized care.
We guarantee reliability, quality and safety in the course of our work.
Document preparation
Our company offers clients a variety of documentation services, including:
Our team of professionals is ready to provide expert assistance in developing the necessary documents and to accompany the entire certification process.
We guarantee individual approach to each project, we take into account customer needs and ensure high quality of work and its timely implementation. We are ready to provide services on preparation of documentation for different sectors and areas of services, ensuring a professional approach and reliability of our work.
- Regulatory and registration documents for validation and qualification of facilities, equipment, engineering and computerized systems, and processes.
- Development of documentation according to ISO 9001, ISO 14000, ISO 22301, ISO 13485, ISO 17025, GMP, EEA, EU and Halal standards.
Our team of professionals is ready to provide expert assistance in developing the necessary documents and to accompany the entire certification process.
We guarantee individual approach to each project, we take into account customer needs and ensure high quality of work and its timely implementation. We are ready to provide services on preparation of documentation for different sectors and areas of services, ensuring a professional approach and reliability of our work.
Document preparation
Our company offers clients a variety of documentation services, including:
Our team of professionals is ready to provide expert assistance in developing the necessary documents and to accompany the entire certification process.
We guarantee individual approach to each project, we take into account customer needs and ensure high quality of work and its timely implementation. We are ready to provide services on preparation of documentation for different sectors and areas of services, ensuring a professional approach and reliability of our work.
- Regulatory and registration documents for validation and qualification of facilities, equipment, engineering and computerized systems, and processes.
- Development of documentation according to ISO 9001, ISO 14000, ISO 22301, ISO 13485, ISO 17025, GMP, EEA, EU and Halal standards.
Our team of professionals is ready to provide expert assistance in developing the necessary documents and to accompany the entire certification process.
We guarantee individual approach to each project, we take into account customer needs and ensure high quality of work and its timely implementation. We are ready to provide services on preparation of documentation for different sectors and areas of services, ensuring a professional approach and reliability of our work.
Audits
Our company offers services for conducting audits of suppliers and outsourcers, as well as technical audits to assess the compliance of products and services with established quality requirements.
Our company provides a full range of auditing services, from preparing for the audit to drawing up the necessary documentation and submitting it to the relevant authorities. We offer an individual approach to each client, take into account his needs and guarantee high-quality performance of work in accordance with the established deadlines.
- Technical audits are conducted to ensure that products and services comply with the quality requirements of the enterprise. In addition, technical audits make it possible to identify problems and deficiencies in production processes, as well as offer recommendations for their elimination.
- Audits of suppliers and outsourcers help assess the performance of suppliers and monitor the quality of the products supplied. As a result of the audit, a quality agreement is drawn up that sets out the requirements for the products supplied, as well as supplier control and approval procedures. The agreement can include product categories such as raw materials and reagents, primary packaging, printed products, eggs, distributors, storage and transportation, quality control, preclinical and clinical trials.
Our company provides a full range of auditing services, from preparing for the audit to drawing up the necessary documentation and submitting it to the relevant authorities. We offer an individual approach to each client, take into account his needs and guarantee high-quality performance of work in accordance with the established deadlines.
Audits
Our company offers services for conducting audits of suppliers and outsourcers, as well as technical audits to assess the compliance of products and services with established quality requirements.
Our company provides a full range of auditing services, from preparing for the audit to drawing up the necessary documentation and submitting it to the relevant authorities. We offer an individual approach to each client, take into account his needs and guarantee high-quality performance of work in accordance with the established deadlines.
- Technical audits are conducted to ensure that products and services comply with the quality requirements of the enterprise. In addition, technical audits make it possible to identify problems and deficiencies in production processes, as well as offer recommendations for their elimination.
- Audits of suppliers and outsourcers help assess the performance of suppliers and monitor the quality of the products supplied. As a result of the audit, a quality agreement is drawn up that sets out the requirements for the products supplied, as well as supplier control and approval procedures. The agreement can include product categories such as raw materials and reagents, primary packaging, printed products, eggs, distributors, storage and transportation, quality control, preclinical and clinical trials.
Our company provides a full range of auditing services, from preparing for the audit to drawing up the necessary documentation and submitting it to the relevant authorities. We offer an individual approach to each client, take into account his needs and guarantee high-quality performance of work in accordance with the established deadlines.
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