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.
Applicable regulations
- Federal law NO. 323-FZ dated November 21, 2011, “ The basics of health protection of the citizens of the russian federation”
- Russian Government . order No. 323 dated June 30, 2004, “ Adoption of the status of the federal service for surveillance in healthcare”
- Russian government . order No. 1416 dated December 27, 2012, “Adoption of rules for state registration of medical devices”
- Ministry’s of Health order No. 737n, dated October 14, 2013, “Adoption of administrative regulation of the Federal Service for Surveillance in Healthcare, provision of state services, and state registration of medical devices”
- Ministry’s of Health order No. 7n dated June 15, 2012, “Approval of the procedures for imports of medical devices into the Russian Federation for the purposes of state registration”
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.
Classification of Medical devices
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 |
State Registration of Medical Devices
Step 1: Application to the Roszdravnadzor
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:
- Name of the device with description of accessories.
- Manufacturer details or Manufacturer’s authorized representative’s details, such as Name, Company details, address, Contact number, etc.
- Detailed address of device manufacturing facility
- Intended use of medical device
- Type of medical device as per classification and nomenclature
- Russian national classification code
- Information about the pathway of registration certificate
Step 2: Preparation of documents
Following are the required documents for the registration of medical devices:
- Copy of the document, confirming Powers of manufacturer’s authorized representative
- Technical documentation of the medical device
- Properties of the product
- Composition and structure
- Geometry, Biological, Electrical, and Electromagnetic Characteristics
- Software requirements
- Operational documentation of the medical device
- Purpose
- Directions for use
- Site of application
- Storage condition
- Information about servicing
- Images of the Device
- Technical test results
- Toxicological test results
- Documents for confirming the results of the trials of the medical devices for the purpose of approval as a type of measuring tools (if required as per the regulation of uniformity in measurement)
- List of documents submitted
- Draft plan of clinical trials
Step 3: (Stage 1) Medical Device Registration
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:
- If the type of device is new,
- The use of new, complex, unique or special methods in mechanism of device,
- If satisfying results are not obtained during evaluation and analysis of clinical data.
Step 4: Clinical trials
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.
Step 5: (Stage 2) Medical device registration
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.
Timeline
About 50 working days after the date the registration decision is made.(Excluding period of clinical trials)
Fees
| Aspect |
Amount |
| Class 1 |
45,000 rubles |
| Class 2a |
65,000 rubles |
| Class 2b |
85,000 rubles |
| Class 3 |
1,15,000 rubles |
Validity
Licenses issued in Russia for medical devices does not expire.
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