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
