Medical Device Regulatory Requirements in Kazakhstan
| 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
|
| Registration Process |
Medical Device Registration
| Click Here
|
| Registration Timeline |
2 to 4 months depending on the classification |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Kazakh and Russian Language |
| Database |
State Register of Medicines and Medical Devices
| Click Here
|
| Additional Information |
During state registration, the validity period of the registration certificate is 5 years |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025