According to the current rules in the Republic of Kazakhstan, the registration of medical devices includes the following stages:
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Collection of the dossier
and receipt of samples
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Signing an agreement with
the state body
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Primary expert examination,
which assesses the completeness, contents, and accuracy of the paperwork submitted by the applicant in the registration dossier
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Analytical expert examination,
including the testing of medical devices samples and determination of the reproducibility of analytical procedures
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Inspection of manufacturing of
medical devices
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Specialized expert examination,
which is implemented by studying the documents of the registration dossier for safety, effectiveness, and quality of medical devices
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Safety statement, which generates
a summary report on the safety, effectiveness, and quality of the medical device
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Assigning a registration number
and issuing a registration certificate for the medical devices