Medical Device Registration
We provide full-cycle registration of medical devices in compliance with national and EAEU requirements
Medical Device Registration
— It is the official process of confirming the safety, quality, and effectiveness of a product before it enters the market.
Products Subject to Registration:
Medical Devices Manufactured or Imported into the Republic of Kazakhstan
Equipment – Apparatuses, Devices, Instruments
(e.g., ultrasound machines, CT scanners, X-ray equipment, laboratory instruments)
Medical Devices
(e.g., syringes, catheters, bandages, surgical instruments, contact lenses, etc.)
Implantable Medical Devices
(e.g., endoprostheses, pacemakers, artificial joints, etc.)
Medical Devices with Software
(e.g., medical imaging systems)
In Vitro Diagnostic Medical Devices
(e.g., test systems, reagents, laboratory diagnostic instruments)
Steps of the Medical Device Registration Procedure
Preliminary Assessment and Consultation
- Calculation of registration costs
- Contract agreement
Dossier Preparation
- Collection of the registration dossier according to the approved list of documents
- Translation of all dossier documents into Russian and Kazakh
- Submission of the application for medical device examination to the NCLSC
- Transfer of the complete dossier package for the medical device to the NCLSC
Examination and Inspection
- Initial examination
- Specialized examination
- Inspection of the manufacturing site (if required)
- Laboratory testing of devices
- Safety assessment
Issuance of the Registration Certificate
Our Advantages
Full Registration Support
A comprehensive service in which we manage all stages of obtaining a registration certificate
We work with both international and local manufacturers
We have extensive experience serving clients from around the world
17 Years of Expertise
Over 1,000 Registered Medicinal Products
CRM System
Thanks to Regicom’s proprietary CRM system, you can monitor projects, registration stages, contracts, and invoices
Get a Quote
