Registration of medical equipment
We deliver the task turnkey
State registration of a medical device (medical equipment) is a procedure for obtaining permission to circulate medical devices on the territory of the Republic of Kazakhstan and entering a medical device for a certain period into the State Register of Medicines and Medical Devices.
Medical devices manufactured in the Republic of Kazakhstan, as well as medical devices imported into its territory, are subject to expertise.
The main purpose of the procedure for medical equipment registration is to establish safety thereof for human health, as well as the quality and effectiveness of the medical equipment.
- 01
20+ years of experience
Working with medical equipment since 2006.
- 02
800+ registrations
Successfully registered medical devices from 35+ manufacturing countries.
- 03
Fast Turnaround
Free initial consultation and timeline estimate.
- 04
Full support
At every stage of the regulatory review until registration certificate is obtained.
Your project is handled by professionals
Makhatova Saule
Head of the Registration Department
Yusupov Almat
State Registration Service Manager
Ualibekova Aizat
Registration Manager
Our services
- State registration/re-registration of medical devices;
- Making changes to the registration dossier of medical devices;
- Entering equipment into the state register of measuring instruments;
- Metrological certification and verification of medical equipment;
- Obtaining conclusions on assessment of the medical devices safety and quality.
Implementation stages
- 01
Inquiry
Receipt of inquiry and a free consultation provision;
- 02
Calculation
Calculation of the registration costs and terms;
- 03
Documentation
Compilation of the registration dossier and preparation of the product technical specification for subsequent market placement;
- 04
Agreement
Conclusion of the contract and submission of the dossier to the expert body;
- 05
Monitoring
Monitoring the process throughout all stages of the regulatory review and timely resolution of expert comments;
- 06
Testing
Participation in testing to obtain a metrological certificate;
- 07
Obtaining registration certificate and certificates
Obtaining of the registration certificate, type approval certificate for measuring instruments, a certificate of conformity.
Tell us your project
We'll send you a quote and a commercial offer.
Design, registration, and equipment delivery, branch renovation, and service—get in touch.
We'll call you back and send you a commercial offer.
- 37 mo Service warranty
- 24/7 Service call centre
- ISO 9001 ST RK · quality management
- Direct Contract without intermediaries