Registration of medical devices in Kazakhstan
The Order of the Ministry of Health of the Republic of Kazakhstan dated November 18, 2009 No. 736 was replaced by the Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. DSM-10 RK «On approval of the Rules for conducting examination of medicines and medical devices».
On February 13, 2023, the EAEU states signed the Protocol on amendments to the Agreement on uniform principles and rules for the circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union.
The document, published on the EAEU legal portal, provides for the possibility of submitting an application for examination or registration of a medical device by December 31, 2025, in the manner prescribed by the law of the EAEU or the legislation of a member state of the EAEU.
You can read the document at the link: https://docs.eaeunion.org/docs/ru-ru/01438265/itia_13022023
The registration process consists of 4 levels:
- Initial examination
- Specialized expertise
- Analytical (laboratory) examination
- Safety Conclusion
Stages and terms of registration of medical devices according to the national procedure
| 1 | Collection of documents | 69 calendar days |
| 2 | Conclusion of the contract, payment for expert work | 5 working days |
| 3 | Submission of the dossier for registration | 1 working day |
| 4 | Expertise | |
| 4.1 | Expertise of medical device class 1 and 2a | 90 calendar days |
| 4.2 | Expertise of medical device class 2b and 3 | 160 calendar days |
| 4.3 | Expertise of medical devices that do not require laboratory testing | 90 calendar days |
| 5 | Payment of state fees | 2 working days |
| 6 | Registration of the registration certificate | 5 working days |
