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The regulation of medical devices in Russia is regulated by the ‘The Federal Service for Surveillance in Healthcare’ i.e. Roszdravnadzor. The Roszdravnadzor works in coordination with the Ministry of Health.
Russia is a member of the Eurasian Economic Commission (EEC) with member states Belarus, Kyrgyzstan, Armenia, and Kazakhstan. The treaty was signed between these countries in 2014 to harmonize the regulations and registration procedures in all EEC countries.
The new procedure was enforced by the EEC in 2016, and the transition period was until December 31, 2021, but that did not happen. Again, on August 19, 2022, the council announced that the transition period had been prolonged until December 31, 2025, so currently the registration process is being followed according to the national regulations.
On the basis of the potential risk the device poses:
Class | Risk | Example |
---|---|---|
Class 1 | Low risk | Medical gauze |
Class 2a | Average risk (Low to Moderate) | The solution for the lens |
Class 2b | Increased risk (Moderate to High) | X-ray apparatus |
Class 3 | High risk | Coronary stent |
To register medical devices in Russia, the manufacturer’s authorized representative has to submit the application to the Roszdravnadzor.
The application includes the following details:
Following are the required documents for the registration of medical devices:
The application and the listed documents should be submitted by the manufacturer or authorized representative after being carefully reviewed.
In this stage, the documents are reviewed for quality, safety, and efficacy requirements. For class 1 medical devices, there is no need to conduct clinical trials. Upon completion of stage 1, the decision is made either to register the medical device or not by the authority. In some cases, the experts request additional data, and then the manufacturer or applicant needs to submit the requested data or information.
Also in this stage, the documents are examined to determine whether the device needs clinical trials or not. The clinical trials are conducted in two types, i.e.,. Involving human participants and Clinical evaluation and analysis of clinical data.
The clinical trials involving human participants are conducted in the following cases:
In this stage, the applicant has to conduct clinical trials if necessary as per the review by the experts. The clinical trials are only conducted after permission by Roszdravnadzor.
The clinical trials are conducted in approved medical institutions by the authority.
Upon completion of clinical trials, the applicant needs to submit the results of the clinical trials to the Roszdravnadzor. Then the expert evaluation is conducted to ensure the quality, safety and effectiveness of medical devices, as well as the completeness of the documents and fulfillment of the requirements. In some cases, the experts request additional data, which is to be submitted by the manufacturer.
After the decision is made by the experts or review committee, within one working day, data about the registered medical device is entered into the State Registry of Medical Devices and Institutions manufacturing and producing medical devices.
About 50 working days after the date the registration decision is made.(Excluding period of clinical trials)
Aspect | Amount |
---|---|
Class 1 | 45,000 rubles |
Class 2a | 65,000 rubles |
Class 2b | 85,000 rubles |
Class 3 | 1,15,000 rubles |
Licenses issued in Russia for medical devices does not expire.
At Maven Profcon Services LLP, we specialize in regulatory consultancy for medical device manufacturers, catering to various needs such as Quality Management Systems (QMS), ISO 13485 certification, USFDA 510k submissions, MDSAP, EU MDR compliance, and Country Registrations in more than 150+ countries. Our comprehensive services ensure a streamlined approach to regulatory compliance, offering you everything you need in one place for successful medical device registration in Russia.
For Medical Devices Registration in Russia, contact us at enquiry@mavenprofserv.com or call +91-7490017774 / +91 7940026222. We’re here to assist you with registering your medical device in Russia.
The medical device regulatory authority in Russia is the Federal Service for Surveillance in Healthcare, known as Roszdravnadzor. It operates under the Ministry of Health and is responsible for overseeing the registration, quality, safety, and effectiveness of medical devices. Manufacturers or their authorized representatives must apply to Roszdravnadzor to register their devices before they can be marketed or used in the Russian Federation.
Medical device registration in Russia typically takes around 50 working days after the decision to register has been made. This timeline does not include the time required to conduct clinical trials, if applicable. The overall process may vary depending on the risk class of the device, the completeness of submitted documents, and whether clinical trials are required based on expert review.
Roszdravnadzor, officially known as the Federal Service for Surveillance in Healthcare, is the main authority responsible for overseeing the regulation and registration of medical devices in Russia. It works closely with the Ministry of Health to ensure that all medical devices meet the country’s safety, quality, and performance standards before they are allowed on the market.
To register a medical device in Russia, you need to submit detailed documentation to Roszdravnadzor. This includes technical specifications, product composition, manufacturing site details, risk classification, intended use, labeling information, testing results, and operational documents like user manuals and storage conditions. Clinical trial data may also be required, depending on the device class and novelty. All documents must be accurate, complete, and aligned with Russian regulatory standards to ensure approval.
Maven Profcon Services LLP provides complete support for registering medical devices in Russia. We assist with document preparation, application submission to Roszdravnadzor, and coordination of technical and clinical evaluations. Our team ensures compliance with Russian national regulations and Eurasian Economic Commission guidelines. With deep expertise and local understanding, we help simplify the registration process and minimize delays, making it easier for manufacturers to enter the Russian market.
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