Preparation and request of documents for state registration
Request and analysis of necessary documents, as well as validation whether such documents were prepared and notarized in accordance with the requirements of the legislation of the Russian Federation
Process and Documents Requirements for State Registration of Medical Devices in Russia
State registration of medical devices is conducted based on the results of technical tests, toxicological studies, and clinical trials. These form the basis for evaluating the conformity of medical devices to technical and operational documentation and applicable standards. This process takes into account the classification of devices depending on the potential risk associated with their use, as well as the examination of their quality, efficacy, and safety.
The registration dossier is a set of documents submitted for the state registration of a medical device. This includes changes to such documents and copies of decisions made by the registering authority regarding a specific medical device.
Key Documentation for Medical Device State Registration under Russian Federation Regulations
For state registration of a medical device under the national regulations of the Russian Federation, the registration dossier typically includes the following key documents:
- A copy of the document confirming the authority of the manufacturer’s authorized representative.
- Information about the regulatory documentation for the medical device.
- Technical documentation from the manufacturer for the medical device.
- Operational documentation from the manufacturer, including instructions for use or a user manual.
- Photographic images of the medical device, along with accessories necessary for its intended use (size not less than 18 x 24 cm).
- Photographic images of the electronic carrier and software interface (size not less than 18 x 24 cm), if applicable, especially for software that is a medical device, including software using artificial intelligence technologies.
- Documents confirming the results of technical tests of the medical device.
- Documents confirming the results of toxicological studies, particularly for devices that come into contact with the human body.
- Documents confirming the results of tests for type approval of measuring instruments (for medical devices classified as measuring instruments in the sphere of state regulation of measurement uniformity).
- An inventory of documents.
- Information verifying the clinical efficacy and safety of medical devices.
- A draft plan for clinical trials of the medical device, with supporting materials, if applicable.
- Information about permissions issued by the registering authority for the import of medical devices for state registration (for foreign-made medical devices, excluding software classified as a medical device).
- Copies of documents confirming the quality of the pharmaceutical product, pharmaceutical substance, biological material, or other substance used or included in the medical device, issued in accordance with the legislation of the country of origin.
The final list of documents is determined by the specific nature of the product, depends on the complexity of the medical device, its risk class, and functional characteristics, and may be supplemented.
Documents submitted as part of the registration dossier for Medical Device State Registration under Russian Federation Regulations of a foreign medical device can be divided into the following groups:
- Documents signed and/or certified by the manufacturer of the medical device (legal documents from the manufacturer confirming the presence of production conditions, quality management system, etc., documents about the relationship with the authorized representative of the manufacturer in Russia and places of medical device production, technical and operational documentation, explanatory letters, etc.)*
*must be certified in the established order in the country of origin, in accordance with international rules of certification (notarization of signature and/or authenticity of document copy, as well as, if necessary, apostille (for countries acceded to the Hague Convention of 5.10.1961) or consular certification (for countries not acceded to the Hague Convention of 5.10.1961).
- Documents signed by the Russian authorized representative of the manufacturer (application for state registration, photographic images, etc.).
- Documents issued and signed by a laboratory or hospital based on the results of tests conducted in the Russian Federation (protocols of toxicological studies, technical tests, tests for electromagnetic compatibility, clinical trials, etc.)
Legal Documents Required from Foreign Medical Device Manufacturers
- Manufacturer’s Company Registration Certificate (e.g., Business License).
- Power of Attorney from the manufacturer for an Authorized Representative in Russia, including details about the company.
- Certificates of Trademark Registration, if the medical device’s labeling or name includes a trademark.
- ISO 13485 Standard Compliance Certificate for the developer, manufacturer, and production sites of medical devices; Audit Report for each provided ISO 13485 certificate.
- If relevant, a European Union Directive Conformity Certificate (CE Certificate) for the medical device manufacturing company.
- Contract between the manufacturer and the production site (if they are separate entities).
Documents in foreign languages must be submitted with a certified Russian translation.
Legal Documents From The Russian Manufacturer
- Certificate of registration of the manufacturer’s company with the tax authority
- Certificate of state registration of a legal entity
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Certificates confirming the registration of a trademark (if there is a trademark on the labeling or in the name of MD).
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Documents confirming the existence of production conditions (legal documents for the premises in which the production of the MD takes place)
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Contract between the manufacturer and the production site (If the legal manufacturer and the production site are different companies)
Our Company’s Expertise in Registration Dossier Compilation
Our experts have extensive experience in compiling registration dossiers for various types of medical devices from numerous countries. We request and analyze all necessary documents for registration, provide advice on document certification, and, if needed, offer recommendations for corrections and proper preparation and certification of all registration dossier documents.
We manage the project through all stages, offering professional assistance in dossier preparation, addressing feedback, and preparing well-argued responses to inquiries from expert services.
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