Adding a medical device to the state register and obtaining a registration certificate (RC) remains a multi-stage but transparent procedure, regulated by Russian Government Decree No. 1416 and ministerial orders of the Ministry of Health. A Meditsinskiy Vestnik correspondent breaks down the key steps that any developer goes through — from determining the risk class to the start of legal sales.
Step 1. Determining the risk class and type code
First, the applicant must establish whether the product qualifies as a medical device and correctly classify it according to the nomenclature classification. There are four potential risk classes: 1 (low), 2a (medium), 2b (elevated) and 3 (high). The class determines the scope of testing required and the duration of the expert review. At the same time, the device is assigned a type code (e.g., tonometer, software, reagent kit). An error at this stage is grounds for registration refusal.
Step 2. Appointing an authorized representative
If the manufacturer is located abroad, it must appoint a Russian authorized representative — a legal entity or individual entrepreneur who will interact with Roszdravnadzor (the Federal Service for Surveillance in Healthcare). This step is omitted for domestic manufacturers.
Step 3. Preparing technical and operational documentation
A set of documents is compiled, including:
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technical specifications;
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user manual in Russian;
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design documentation;
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a list of standards the device complies with (GOST, ISO, IEC);
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an ISO 13485 quality management system certificate (if available).
Step 4. Technical testing
The device is sent to a laboratory accredited by the Federal Accreditation Service to verify the declared characteristics. Depending on the type of product, electrical safety, electromagnetic compatibility, measurement accuracy, resistance to environmental factors, sterility, and other parameters are assessed. The result is a technical test report.
Step 5. Clinical trials
For risk classes 2a, 2b and 3, as well as for certain class 1 products (e.g., software with diagnostic functions), clinical evidence of effectiveness and safety is required. Trials are conducted at a medical organization authorized for this type of activity. The scope of the study is determined by the risk class: from limited observations involving a few dozen patients to large-scale multicenter studies. The outcome is a clinical trial report.
Step 6. Compiling the registration dossier
The set of documents established by Ministry of Health Order No. 11n includes the application, manufacturer information, normative documentation, photographs, both test reports, and proof of state duty payment. A power of attorney for the authorized representative is attached when required.
Step 7. Submission of the application and expert review
The dossier is submitted to Roszdravnadzor via the Gosuslugi portal or directly. After a completeness check, the documents are forwarded to an expert institution (such as the Federal State Budgetary Institution “VNIIIMT” or a similar entity). The expert review of quality, effectiveness, and safety involves analysis of the provided materials and, if necessary, an inspection of the manufacturing site. For high-risk devices, the expert review may take up to several months.
Step 8. Obtaining the registration certificate and placing on the market
With a positive conclusion, Roszdravnadzor enters the device into the state register and issues a perpetual registration certificate (for most categories). From that moment, the product can be legally sold and used in medical institutions, and the packaging must bear the “RZN” mark of circulation together with the certificate number.
After entering the market, the manufacturer is obliged to conduct post-registration surveillance: collecting and submitting to the supervisory authority information on any adverse reactions or incidents associated with the use of the device.
The total duration of the procedure depends on the risk class and the completeness of the documentation. For simple class 1 devices, the cycle may take 3–5 months; for class 2a, 6–10 months; and for high-risk products of classes 2b and 3, 10–14 months or longer. According to Roszdravnadzor, the share of refusals on formal grounds decreased by 15% in 2025, which is attributed to improved electronic interaction and clear dossier templates.
