Registration of medical devices is a state procedure aimed at allowing the release of high-quality and safe medical devices, medical equipment and medical equipment to the Russian market. Which must pass the quality and safety assessment procedure without fail.
Before starting registration, medical products should be studied, understood their specifics, functional purpose and the area in which they will be used.
- Preparation of the registration dossier
- Toxicological and technical tests
- Stage of quality and safety expertise
- Clinical trials
- Examination stage-confirmation of application
- Obtaining a registration certificate for a medical device.
- For medical devices that have been subject to a special expedited clearance procedure (products of special demand during a pandemic: masks, gloves, suits, etc.), the deadline depends on the specific type of goods, but can be reduced to 1.5 months from the date of submitting an application to the agency;
- For medical devices intended for initro diagnostics and medical devices of the 1st class of potential risk of use: 6-9 months.
- For other medical devices: 8 months-1.5 years (for complex devices that require extensive testing).
Medical registration certificates are issued on a state-issued letterhead and do not have a validity period, except for goods whose registration process is of a special nature.
Documents for registration of medical devices
- Power of attorney confirming the authority of the manufacturer's (manufacturer's) authorized representative in the Russian Federation. If the registration is performed by another company, a power of attorney to perform registration actions is required (from the manufacturer or by an authorized representative).
- Certificate of free sale in the manufacturer's country (if available).
- ISO certificate for the manufacturing site(s).
- Information about regulatory documentation for the medical device (which approved standards, norms, TU, GOSTs, etc. corresponds to the MI - its production, technical characteristics, functioning, packaging, labeling, etc.).
- Manufacturer's (manufacturer's) technical documentation for the medical device1);
- Manufacturer's (manufacturer's) operational documentation for the medical device (instructions for use or operation manual);
- Photographic images of the general appearance of a medical device along with accessories necessary for intended use of the medical device (sized at least 18 x 24 centimeters);
- For medical devices of the 1st class of potential risk of use and medical devices for in-vitro diagnostics - information confirming clinical effectiveness and safety of medical devices;
- Copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material and other substance with which the medical device is manufactured or which are part of it and which are intended for use only in view of the intended use of the medical device specified by the manufacturer, and issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material and other substance (IF AVAILABLE);
- All documents shall be certified by the manufacturer: signature, seal, notary certification of the signature, the documents under #1-3 must be legalized (apostilled or by Russian consulate);
- List of documents for state registration of a medical device in the Russian Federation (PDF).
All documents are certified by the manufacturer: signature, seal, notarization of the signature, documents under No. 1-3 must be legalized (apostille or Russian consulate).
1) the name of the medical device, other information that allows identifying the medical device, for example, the model number, variants of modifications (versions) of the medical device;
2) purpose of the medical device and principles of operation;
3) indications and contraindications for use;
4) information about potential customers;
5) description of the main functional elements of the medical device, with drawings, diagrams and other explanations;
6) description of the components (components) of the medical device(if any);
7) a description of accessories, medical devices or products that are not medical, but are intended for use in combination with the declared medical device (if any);
8) a list, description and brand of medical device materials that come into direct or indirect contact with the patient's body (human body);
9) data on labeling of the medical device and its packaging;
10) a list of risks identified in the risk analysis process and a description of how to manage these risks in order to reduce them to an acceptable level (if any);
11) information on verification and validation of the medical device that was used to prove the compliance of the medical device with the established requirements, including the results of: a) tests in testing laboratories (centers); b) laboratory and (or) factory tests, including the results of tests under conditions simulating operational ones; c) laboratory tests on animals to confirm the correctness of the concept of the finished medical device;
12) a list of materials of animal and (or) human origin with information on their biological compatibility and safety, selection of sources (donors), sampling, processing, storage and handling of these materials (if any);
13) information on the tests performed, test reports, analysis of the data obtained;
14) references to previous modifications of a medical device or similar modifications of medical devices in circulation, if information about similar or previous modifications of a medical device is used in the technical documentation to prove that the medical device meets the safety and effectiveness requirements;
15) information on the main stages of designing a medical device and manufacturing processes, which may be accompanied by diagrams, photographic images, drawings, diagrams and other explanations;
16) information on the following items contained in the medical product: a medicinal product for medical use, including the name (international nonproprietary, or grouping, or chemical and commercial), the name of the manufacturer, the date and number of the registration certificate; a pharmaceutical substance, including the name (international nonproprietary, or grouping, or chemical and commercial). trade name), the name of the manufacturer of the pharmaceutical substance, the date and number of the registry entry of the state register of medicinal products for medical use;
17) a description of the sterilization method, information on validation methods for the sterilization process (including tests for biological load, the presence of pyrogenic substances, the presence of a residual amount of sterilizing substance) and on the validation of the packaging process (if the medical device is delivered in sterile form);
18) information on the process of designing, developing and validating software used in the finished medical device (if the medical device has software that ensures its proper operation and (or) intended use);
19) requirements for maintenance and repair of a medical device;
20) procedure and conditions for disposal or destruction of a medical device;
21) Requirements for technical documentation of a medical device (PDF).
- description of the purpose of the medical device, including:
a) a description of the target analysis, information about its scientific validity,an indication of the qualitative, semi-quantitative or quantitative type of analysis;
b)functional purpose (for example, screening, monitoring, diagnostics or an auxiliary tool in diagnostics);
c) aspecific pathology,condition or risk factor that the invitro diagnostic device is intended to detect, determine or differentiate;
d)type of sample to be analyzed;
e) population and demographic aspects of the use of a medical device; - specification of the professional level of potential users (for example, a doctor of clinical laboratory diagnostics, a medical laboratory technician (paramedic-laboratory assistant), or other specialist).
- description of the principle of the analytical method or the principle of operation of a medical device,for analytical equipment - the corresponding technical characteristics;
- description of transportation conditions;
- information about analytical sensitivity (detection threshold), analytical specificity, diagnostic sensitivity, and diagnostic specificity.
- description of measurement procedures,metrological traceability of calibrator values and control materials;
- data on the stability of the medical device, confirming the declared shelf life, stability during use and stability during transportation;
- Requirements for technical documentation of a medical device for initro diagnostics (PDF).
If changes are made to the documents of the registration dossier for a medical device that do not require an expert examination of the quality, effectiveness and safety of the medical device, the following documents are submitted:
- applicationfor state registration of a medical device
- a copy of the document confirming the authority of the authorized representative of the manufacturer (s);
- information about the regulatory documentation for a medical device;
- technical documentation of the manufacturer (s) for the medical device;
- operational documentation of the manufacturer (s) for the medical device, including instructions for use or operating instructions for the medical device;
photographic images of the general appearance of the medical device together with accessories necessary for the intended use of the medical device (size less than 18 x 24 centimeters);
- documents confirming the results of technical tests of a medical device;
- documents confirming the results of toxicological studies of a medical device, the use of which implies contact with the human body;
- documents confirming the results of tests of a medical device for the purpose of approving the type of measuring instruments (in relation to medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements)
Regulatory documentation
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