| Regulatory Authority | National Center for Expertise of Medicines and Medical Devices |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Regulatory acts on national expertise | Click Here |
| Device Classification Guidelines | Rules for classification of medical devices | Click Here |
| Registration Process | Medical Device Registration | Click Here |
| Registration Timeline | 2 to 4 months depending on the classification |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labeling shall be unified for each series (batch) of medical device and shall be indicated in the Kazakh and Russian Language |
| Labeling Requirements |
Rules for labeling medical devices | Click Here |
| Clinical Trials Information |
Expertise of clinical trial materials for medical devices | Click Here |
| Database | State Register of Medicines and Medical Devices | Click Here |
| Additional Information | Registration of medical devices according to the EAEU procedure is carried out in accordance with the established Rules for the registration and examination of the safety, quality and effectiveness of medical devices ( Legal portal - View document (eaeunion.org) ). During state registration, the validity period of the registration certificate is 5 years |