registration
AND СERTIFICATION
medicinal products
and medical devices
and medical devices
Speed of processing, favourable prices and registration guaranteed!
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Permit the importation of unregistered medicines and medical devices
Registration of medical devices (medical devices and medical equipment)
We provide services for the full support of the registration of medical devices − from the preparation of a registration dossier to obtaining a state registration certificate.
State registration and re-registration are subject to medical devices manufactured in the Republic of Kazakhstan, as well as imported into its territory (medical devices and medical equipment), including:
- Medical products under trade names from each production site;
- Consumables for medical devices, except those specially designed by the manufacturer of the medical device for use with medical devices capable of functioning only with these consumables;
- Medical devices that are part of a specialized vehicle for medical care;
- Bulk-products of medical devices.
State registration is not subject to:
- Medical devices made by individual orders of patients exclusively for personal use, which are subject to special requirements in accordance with the appointment issued by a medical professional;
- Medical devices manufactured in the Republic of Kazakhstan for export only;
- Exhibition samples of medical products for exhibitions without the right of their further sale;
- Samples of medical devices received for preclinical (non-clinical) and clinical studies and (or) tests;
- Laboratory devices not used for the diagnosis of diseases;
- Components that are part of medical devices and are not used as an independent product or device;
- Samples of medical devices for examination during state registration.
More than 70 types of documentation
from certificates of conformity to registration of medicines and medical devices
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Kazakhstan, Shymkent, mrk. Akzhayik 26/1
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