+7 (499) 938-69-54
Moscow, 12A Bolshoy Kharitonevsky, Office 5, 2nd Floor 101000
+7 (812) 425-64-03
St. Petersburg, 8 Troitsky Prospekt, Office 12, 2nd Floor 101000
info@medizd.ru
Mon-Fri: 09:00-18:00
Eng Rus
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Medical Device Registration Center
Medical Device Registration Center
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    Medical Device Registration Center
    Main
    Services
    • Medical products
      • Processing of registration certificates
      • State registration of medical products
    • Amendments
      • Processing of registration certificates
      • Amendment of registration dossiers
      • Amendment of registration certificates
    • Testing of medical products
      • Clinical trials
      • Toxicological testing
      • Technical testing
    Education
    • Образовательная лицензия
    • Образовательные программы
    • Документы
    • Документы об организации
    • Основные сведения
    • Структура и органы управления
    • Уровни образования, формы обучения
    • Материально-техническое обеспечение
    Prices
    About the company
    • About the company
    • Client feedback
    • Clients
    Articles
    Contact info
      Eng Rus
      Medical Device Registration Center
      • Main
      • Services
        • Назад
        • Services
        • Medical products
          • Назад
          • Medical products
          • Processing of registration certificates
          • State registration of medical products
        • Amendments
          • Назад
          • Amendments
          • Processing of registration certificates
          • Amendment of registration dossiers
          • Amendment of registration certificates
        • Testing of medical products
          • Назад
          • Testing of medical products
          • Clinical trials
          • Toxicological testing
          • Technical testing
      • Education
        • Назад
        • Education
        • Образовательная лицензия
        • Образовательные программы
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        • Материально-техническое обеспечение
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      • +7 (499) 938-69-54
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        • +7 (499) 938-69-54
        • +7 (812) 425-64-03
        • Schedule a call
      Moscow, 12A Bolshoy Kharitonevsky, Office 5, 2nd Floor 101000
      info@medizd.ru
      Medical Device Registration Center
      • Main
      • Services
      • Testing of medical products

      Testing of medical products

      Clinical trials
      starting at RUB 100 000
      Details

      Toxicological testing
      starting at RUB 80 000
      Details

      Technical testing
      starting at RUB 70 000
      Details

      Qualification testing of medical products

      Pursuant to applicable Russian legislation, the procedure for bringing a new medical product to market entails conformance with a number of serious conditions. The final stage before the product starts getting stocked on pharmacy shelves is its obtainment of a registration certificate (RC). Prior to that, however, the product must undergo a lengthy series of evaluation procedures.

      Once the product’s composition has been developed and adjusted, the manufacturer starts working on organizing mass production. From that very moment, all of the manufacturer’s activities come under the state’s strict control. The first batch of mass-produced product must undergo mandatory qualification testing.

      Testing of medical products for the purposes of qualification

      The main purpose of organizing qualification testing is to evaluate the manufacturer’s preparedness to proceed with the mass production of its product on an industrial scale. This testing is conducted for the first batch of product the manufacturer produces, which is also known as the pilot batch. In order to arrange for such testing, the company must contact an authorized organization accredited by Roszdravnadzor.

      The Center for the Registration of Medical Products holds a valid accreditation certificate and offers services aimed at the performance of qualification testing on medical products. This testing is organized in compliance with the requirements of the national standards GOST R 15.013-2016 and GOST R 15.301-2016. It is conducted in the following sequence:

      • creation of a special commission tasked with organizing and conducting the required tests;
      • development of a control program, including the methodology for evaluating the product’s properties;
      • analysis of documents pertaining to the medical product;
      • preparation of the required equipment, which must pass mandatory inspection and calibration;
      • performance of a qualification test of the product batch;
      • compilation of a report on the findings of the completed tests, per the standard form;
      • issuance of a decision on the testing result and compilation of a confirming document in the form of an act on qualification testing.

      The result of the completed work will be considered positive if the products from the pilot batch have confirmed their conformance with all of the requirements reflected in the respective program. The manufacturer must also obtain positive evaluations according to select parameters: the fitting of the production process with the required equipment and achievement of stable characteristics within the scope of the production run. The characteristics binding on conformance evaluation are prescribed in the respective design and technical documentation.

      • Medical products
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      • Testing of medical products
        • Clinical trials
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      Medical Device Registration Center

      Center for the Registration of Medical Products.

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      +7 (499) 938-69-54
      141280, Moscow region, city of Ivanteevka, Fabrichny proezd, house 1 position 40, floor/room 2/95a
      +7 (812) 425-64-03
      St. Petersburg, 8 Troitsky Prospekt, Office 12, 2nd Floor
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      info@medizd.ru
      Mon-Fri: 09:00-18:00
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