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Changes in the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System”

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Changes in the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System”

Dear partners!

You are hereby informed that Order No. 736 of the Health Minister of the Republic of Kazakhstan «On Approval of the Rules for Expert Examination of Medicinal Products and Medical Devices» entered into force on May 15, 2019.

Major changes in the state registration, re-registration and the process of amending registration documents for medical devices:

  • Several modifications of a certain medical device may be included in a single registration
    dossier subject to the following conditions:
    1) the medical device modifications have been carried out by the same manufacturer and have common structural features;
    2) the medical device modifications refer to the same class of potential risk of application;
    3) the medical device modifications have a common functional purpose;
    4) the medical device modifications have a common scope of application;
    5) the medical device modifications provide for uniform rules for operation and
    maintenance.
  • In the course of the medical device expert examination, the state expert organization
    establishes conformity of the declared class depending on the degree of potential risk of application in accordance with the Rules for Classification of Medical Devices Depending on the Degree of Potential Risk of Application, approved by the competent authority pursuant to paragraph 2 of Article 83 of the Code.
  • As refers to medical devices with respect to which a perpetual registration
    certificate/marketing authorization was issued, the state organization carries out periodic benefit/risk ratio assessment based on the continuous safety monitoring.
  • The manufacturer or the authorized representative of the manufacturer of the medical
    device shall within two months amend the registration dossier based on safety monitoring data, quality and efficacy of medical devices approved by the competent authority pursuant to paragraph 3 of Article 85 of the Code.
  • The application form for the registration dossier submission has been updated.
  • Corrections and additions have been added to the list of the registration dossier documents for the expert examination of the medical device.
    As refers to the medicinal products registration process, an important change is that the dossier for re-registration shall be submitted for expert examination not less than 180 days before the expiry of the registration certificate/marketing authorization.
    You are hereby informed that the Code of the Republic of Kazakhstan «On Public Health and the Healthcare System» was changed and supplemented on April 19, 2019, and according thereto, the concepts of «medical equipment» and «medical products» were united to form the concept of «medical devices».

Based on the changes in the Code of the Republic of Kazakhstan «On Public Health and the Healthcare System» as relate to the definition of the «medical devices» concept the following orders have also been amended:

  • Order No. 227 of the Minister of Health and Social Development of the Republic of
    Kazakhstan dated April 16, 2015 «On Approval of the Medicinal Products and Medical Devices Labeling Regulations» dated 22.04.2019.
  • Order No. 414 of the Minister of Health and Social Development of the Republic of
    Kazakhstan dated May 29, 2015 «On Approval of the Rules for Preparation and Drawing up of Instructions for Medical Use and Summary Characteristics of Medicinal Products and Medical
    Devices» dated 24.04.2019.

 

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