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The procedure for state registration and amendments to the registration dossier of medical devices under the new requirements in the Kyrgyz Republic

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The procedure for state registration and amendments to the registration dossier of medical devices under the new requirements in the Kyrgyz Republic

Pursuant to the order No. 311 from 5 July 2018, the list of the registration dossier documents for the examination of medical devices was amended. The full list of documents is listed below.

Also, the registration process will include the inspection of production sites as specified in the new requirements.

Reasons for assessing the production conditions are specified in the diagrams.

Medical devices that are registered as medical devices in the country of origin or in other countries and received an affirmative expert assessment of safety, quality and efficacy are subject to state registration in the Republic of Kyrgyz.

The application for state registration of a medical device shall include:

  • the registration dossier of the medical device (hereinafter - the registration dossier) containing the documents as to the List as directed by Appendix 1 in hard copy and/or electronic media, in duplicate.
  • the samples of medical devices in the quantity required for research (testing) as required by the standard for the medical device. Samples are not provided to medical equipment and medical devices for in vitro diagnostics;
  • the specific reagents in the quantity required for research (testing) as required by the standard for the medical device.

The state registration of the medical device is carried out within a period not exceeding 90 calendar days from the date of receipt of the application.

The inspection of production to be carried out as part of the state registration procedure shall be implemented by the authorized body upon any of the following:

- the production of a medical device previously registered in the Kyrgyz Republic was not inspected;

- the production of a medical device is carried out on the first-time applied production site of the applicant;

- when applying for registration of the first reproduced medical device;

- in cases where an analytical examination is impossible due to the high cost of medical device samples, the impossibility of meeting the transportation and (or) storage conditions of the specified samples, and the lack of special equipment and consumables. In this case engineering tests (studies) are made in the presence of representatives of the authorized body in the quality control laboratory of the medical device producer or in the contract laboratory used by the producer;

- the impossibility of assessing the reliability of data on the safety, efficacy and quality of a medical device according to the documents as submitted in the registration dossier.

Production inspection is implemented in the manner approved by the Government of the Kyrgyz Republic.

The term for organizing and conducting an inspection is not included in the general period of the examination and should not collectively exceed 90 calendar days.

The list of documents to be required for registration of a medical device:

  1. A power of attorney from the producer for the right to represent interests at registration (if necessary);
  2. A copy of the permit document on the right of production in the country of origin with the attachment (if any);
  3. Copies of certificates for the quality management system of the producer of medical devices (ISO 13485 or the relevant regional or national standard) (if any);
  4. A Declaration of conformity with the requirements of the safety and efficacy of medical devices or an equivalent document (if any);
  5. A copy of the marketing authorisation issued in the country of the producer with the certified translation into Russian (if any);
  6. A copy of the document certifying the registration in other countries (if any);
  7. Information on labelling and packaging (full-colour layouts of packages and labels, labelling text in the official and/or state language);
  8. GTIN barcode (EAN13; designed to uniquely identify a product) (if any);
  9. Information on the development and production: production processes flow – chart, the diagram of the basic stages of production, packaging, testing and procedures for the release of the final product;
  10. Information about the producer: name, type of activity, legal address, form of ownership;
  11. Accident and feedback reports (information is not provided for newly developed and designed medical devices):
  12. a list of undesirable events or accidents associated with the use of the product, and an indication of the period of time during which the specified cases occurred;
  13. if there are too many undesirable events, you should provide brief overviews for each of the event types and indicate the total number of each type of events about which reports were received;
  14. a list of reviews from the market of medical devices and (or) explanatory notices and a description of the approach to the consideration of these issues and their solution by producers in each of these cases;
  15. description of the analysis and / or corrective actions taken in response to the specified events;
  16. The list of standards to which the medical device conforms (indicating the information about the standards);
  17. Information on the compliance of the medical device with the general requirements of safety and efficacy of medical devices, requirements for their labelling and instruction manuals for them;
  18. A document establishing requirements for the specifications of a medical device;
  19. Engineering test reports to be conducted to prove compliance with general requirements;
  20. Study reports (test reports) to assess the biological effect of a medical device, conducted in order to prove compliance with the general requirements;
  21. A Report on clinical evidence of the effectiveness and safety of a medical device;
  22. Risk Analysis Report;
  23. Data on medicinal products in the composition of the medical device (composition of the medicinal product, quantity, data on the compatibility of the medicinal product with the medical device, on registration of the medicinal product in the country of origin);
  24. Biological safety data (if any);
  25. Data on the sterilization procedure, including information on the process validation, test results for the content of microorganisms (degree of biological burden), pyrogenicity, sterility (if necessary), indicating test methods, and data on packaging validation (for sterile products);
  26. Information on special software, information from the producer on software validation (if any);
  27. Report on stability studies - with an authentic translation into Russian of the results and conclusions of tests for products with a shelf life;
  28. Instruction manual or instructions for use of the medical device;
  29. Service manual (in terms of components of a medical device) - in the absence of data in the instruction manual (if any);
  30. Production inspection report (if any);
  31. A plan for the collection and analysis of data on the safety and efficacy of medical devices at the post-sale period (if any);
  32. Documents confirming the results of medical devices tests for the purpose of approving the type of measuring instruments (in relation to medical devices classified as measuring instruments) (if necessary).

Best regards,
MedExpert Eurasia
http://medexpert.group/ru

 

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