Medical devices are any instruments, apparatuses, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for prevention, diagnosis, treatment and medical rehabilitation diseases, monitoring the state of the human body, conducting medical research, recovery, replacement, changes in the anatomical structure or physiological functions of the body, prevention or termination of pregnancy, the functional purpose of which is NOT realized by pharmacological, immunological, genetic or metabolic effects on the human body. Medical devices can be recognized as interchangeable if they are comparable in functional purpose, quality and technical characteristics and are able to replace each other.
The circulation of medical devices includes technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical devices, their state registration, production, manufacture, import into the territory of the Russian Federation, export from the territory of the Russian Federation, conformity assessment, storage, transportation, sale, installation, commissioning, application, operation, including maintenance which provided by the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer), as well as repair, disposal or destruction.
On the territory of the Russian Federation, circulation of medical devices that have passed state registration in accordance with the procedure established by the Government of the Russian Federation (local rules) and medical devices that have been registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union is permitted (EEU rules).
Class 1
Class 2a
Class 2b
Class 3
* 1₽ = 0.01$
Algorithm of state registration of medical devices for circulation on the market of medical devices within the Russian Federation, in accordance with Federal Law No. 323-FZ of November 21, 2011 “On the basics of public health protection in the Russian Federation”:
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Analyzing your taskAt the very beginning of the work, it is necessary to consider all the features of your medical device. Also, we need to determine the optimal strategy for its registration, choosing a procedure in accordance with a particular Decree of the Government of the Russian Federation.
The volume of materials provided and the necessary tests depend on it. It directly affects time and costs.
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Preparation of submission form for registrationIt is necessary to clearly prescribe the composition of the device, accessories (if any), correctly and broadly reflect its purpose and other fundamental features like risk class, type, coding, etc. The application for state registration, in fact, is a "skeleton" on which all the requested information will be layered when preparing a registration dossier for a medical device.
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Documentation preparationWhen preparing technical and operational documentation, we involve engineers and biochemists (for in-vitro products). Direct contact of engineers and biochemists with own testing center, as well as with partner testing centers and clinical co-executors, allows to identify all the requirements of the standards that a medical device must meet before starting work with the manufacturer's documentation. We also take into account the accumulated experience of recommendations and comments already received from experts of the Roszdravnadzor and experts of subordinate organizations.
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Testing— development of test programs specifically for your medical device;
— calculation of the timing and cost of each type of required tests and studies.
When choosing test centers, we consider:
— the scope of accreditation, covering all standards applicable to your medical device;
— test equipment available;
— practical experience in conducting tests of this type of medical devices;
— availability of the required types of work in the license to carry out medical activities (in the case of clinical trials);
— availability of the technical base and availability of the required volume of biomaterial (in the case of clinical and laboratory studies of in-vitro products).
Our team evaluate the tests performed and verify the recorded results.
For foreign medical devices, as well as products manufactured at foreign production sites by order of a Russian manufacturer, we will pre-coordinate with testing centers and clinical bases the volume of necessary samples for all types of required studies. The necessary documentation package is prepared and a application of the import permission of samples is submitted to the Roszdravnadzor.
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Support of the application during expertise in RoszdravnadzorYour personal manager constantly monitors the passage of examinations of the dossier in Roszdravnadzor.
If there are Notifications about the need to provide additional action/explanation, we immediately evaluate the requirements for legality and finds optimal solutions to resolve them.
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Registration certificate issuance and entry into the "State Register of Medical Devices and organizations engaged in the production and manufacture of medical devices"Algorithm of state registration of medical devices for circulation on the common market of medical devices within the framework of the Eurasian Economic Union, in accordance with the law of the Eurasian Economic Union:
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Analyzing your taskThe volume of materials provided and the necessary tests depend on it. It directly affects time and costs.
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Preparation of submission form for registrationThe application for state registration, in fact, is a "skeleton" on which all the requested information will be layered when preparing a registration dossier for a medical device.
●●●○○○○○○
Documentation preparationDirect contact of engineers and biochemists with own testing center, as well as with partner testing centers and clinical co-executors, allows to identify all the requirements of the standards that a medical device must meet before starting work with the manufacturer's documentation. We also take into account the accumulated experience of recommendations and comments already received from experts of the Roszdravnadzor and experts of subordinate organizations.
●●●●○○○○○
TestingWhen choosing test centers, we consider:
— the scope of accreditation, covering all standards applicable to your medical device;
— test equipment available;
— practical experience in conducting tests of this type of medical devices;
— availability of the required types of work in the license to carry out medical activities (in the case of clinical trials);
— availability of the technical base and availability of the required volume of biomaterial (in the case of clinical and laboratory studies of in-vitro products).
Our team evaluate the tests performed and verify the recorded results.
For foreign medical devices, as well as products manufactured at foreign production sites by order of a Russian manufacturer, we will pre-coordinate with testing centers and clinical bases the volume of necessary samples for all types of required studies. The necessary documentation package is prepared and a application of the import permission of samples is submitted to the Roszdravnadzor.
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Support of the application during expertise in RoszdravnadzorYour personal manager constantly monitors the passage of examinations of the dossier in Roszdravnadzor.
If there are Notifications about the need to provide additional action/explanation, we immediately evaluate the requirements for legality and finds optimal solutions to resolve them.
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Inspection of manufacturing siteFor sterile medical devices, as well as medical devices of risk classes 2b and 3, the norms of legislation requare for inspection of production. For both domestic and foreign manufacturers of medical devices.
The inspection is carried out by accredited organizations.
Our staff will provide all necessary methodological support during this stage of registration of a medical device, as well as perform all necessary actions to conclude a contractual relationship with the inspection organization.
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Support of the application during expertise in RoszdravnadzorIf there are Notifications about the need to provide additional action/explanation, we immediately evaluate the requirements for legality and finds optimal solutions to resolve them.
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Passing the procedure for approving an expert opinion in the countries of recognition.After issuing a conclusion on the assessment of the safety, effectiveness and quality of a medical device, the expert organization of the reference state sends this conclusion and the relevant documents of the registration dossier for approval to the expert organizations of the recognition states.