Registration of medical devices
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.
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.
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).
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);
Federal Law of the Russian Federation No. 323-FZ of 21.11.2011 On the Fundamentals of Public Health Protection in the Russian Federation (as amended on 24.04.2020)
Decree of the Government of the Russian Federation No. 1416 of 27.12.2012 On Approval of the Rules for State Registration of Medical Devices (as amended on 18.03.2020)
Decree of the Government of the Russian Federation No. 323 of 30.06.2004 On Approval of the Regulations on the Federal Service for Supervision of Healthcare (as amended on 26.11.2019)
Leave a request and we will contact you as soon as possible
* — By submitting your data, you are protected by the Federal Law «On Personal Data Protection».
® ALL RIGHTS RESERVED DESIGN BY ARTEM GETMANN
Leave a request and we will contact you shortly