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10/01/2020 08:35:54

Moscow

10/01/2020 07:35:54

LUDWIGSBURG

Exchange rates

92,43 RUR

$78,78 RUR

Registration of medical devices

Registration of medical devicesImport, sales and implementation of medical products in the Republic of Kazakhstan are allowed only after official registration of them.

 

Registration process of medical products in Kazakhstan is regulated with two main laws:

  • Code of the Republic of Kazakhstan from 18.09.2009 "Public health and healthcare system"
  • Statement № 84 of MOH of the Republic of Kazakhstan from 15.02.2012 "Concerning approval of rules for official registration, re-registration and introduction in amendments to registration documentation of medical products, medical devices and medical equipment"

 

Grounds for starting registration process are application for registration and related set of documents on exact products, which is supposed to use in medical sphere.

An applicant takes full responsibility for the quality, safety and efficiency of a medical product.

 

Necessary documents for obtaining Registration Certificate for medical devices:

  • Power of attorney for representing manufacturer during registration process
  • Copy of an extract from the trade register
  • Copy of ISO 13485 and/or ISO 9001
  • Copy of CE certificate
  • Technical information on products (catalogues, passports, test protocols, operating manuals, risks analysis, list of implemented materials, etc.) in Kazakh and Russian language with a company stamp and a signature of responsible person / employee
  • Sample units for tests (if required)
Other documents can be required.

 

IMPORTANT ISSUES:

  • All documents must be in Kazakh and Russian languages
  • Expert inspection of production can be required depending on type of medical products
  • Expert organization determines validity period of Registration certificate. Validity period for medical products is 5 years and for medical equipment is 7 years
  • At the end of validity period of a Registration certificate medical products must be re-registrated. An application can be submitted until the date of expiry of the Registration Certificate, or no longer than 6 months after a date of expirecy

 


 

Please, send us your request and our experts will check which certificates are required for the import of your goods to the territory of the Republic of Kazakhstan.

For more information, please contact us!                                          Contact

E3M Business Consulting GmbH

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