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+ лет опыта
Years of experience
- 02
800+ регистраций
Registered medical devices
- 03
Короткие сроки
Manufacturing countries
- 04
Полное сопровождение
Customer companies
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 file 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
Bid
Receipt of an application and a free consultation provision;
- 02
Calculation
Calculation of the registration cost and terms;
- 03
Collection
Collection and forming a file, drawing up technical specification for the product, taking into account further realization;
- 04
Agreement
Conclusion of the contract and submission of the file to the expert body;
- 05
Monitoring
Monitoring of the process at all stages of the expertise, timely elimination of any faults commented by the experts;
- 06
Trials
Participation in testing to obtain a metrological certificate;
- 07
Obtaining a RU and certificate
Obtaining of the registration certificate, a certificate for approval of the measuring instrument type, 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.
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- 37 mo Service warranty
- 24/7 Service call centre
- ISO 9001 ST RK · quality management
- Direct Contract without intermediaries