Public Health and Healthcare System Act No. 360 of the Republic of Kazakhstan, adopted on July 7, 2020, establishes mandatory state registration of medical devices manufactured both within the country and imported from abroad.
LEGAL FRAMEWORK
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Diagnostic Equipment
(Ultrasound systems, X-ray units, magnetic resonance imaging systems, endoscopes, and other diagnostic devices)
(Ultrasound systems, X-ray units, magnetic resonance imaging systems, endoscopes, and other diagnostic devices)
Devices for the Treatment and Prevention of Diseases
(Physiotherapy equipment, surgical devices, inhalation systems, and other medical equipment)
(Physiotherapy equipment, surgical devices, inhalation systems, and other medical equipment)
Rehabilitation Devices and Aids
(Orthopedic products, prosthetic devices, walkers, canes, wheelchairs, and other rehabilitation products)
(Orthopedic products, prosthetic devices, walkers, canes, wheelchairs, and other rehabilitation products)
Implantable Medical Devices
(Pacemakers, joint prostheses, dental implants, and other implantable prёoducts)
(Pacemakers, joint prostheses, dental implants, and other implantable prёoducts)
Health Monitoring and Self-Monitoring Devices
(Blood glucose meters, blood pressure monitors, pulse oximeters, thermometers, and other monitoring devices)
(Blood glucose meters, blood pressure monitors, pulse oximeters, thermometers, and other monitoring devices)
Consumables and Accessories for Medical Equipment
(Catheters, electrodes, single-use instruments, and other medical consumables)
(Catheters, electrodes, single-use instruments, and other medical consumables)
The following products are subject to state registration:
Preparation of a consolidated report on the safety, quality, and effectiveness of the medical device
Issuance of the Medical Device Registration Certificate
The following parameters are evaluated to confirm the safety and quality of medical devices:
- Biological safety or biological effect assessment;
- Physical characteristics;
- Mechanical characteristics;
- Functional characteristics;
- Technical characteristics;
- Physicochemical characteristics.
Conducted by testing laboratories of the state expert organization to confirm compliance with the safety and quality characteristics of the medical device declared in the manufacturer's quality documentation
Expert assessment
Review and analysis of registration dossier documentation
The purpose of this stage is to confirm the safety, quality, and effectiveness of the medical device
Conducted during the expert review process for the state registration of medical devices
- Initial inspection;
- Periodic (scheduled) inspection;
- Unscheduled inspection.
Performed as part of monitoring the safety, quality, and effectiveness of medical devices in the following forms:
Assessment of the completeness, adequacy, and compliance of the registration dossier documentation
Documents submitted by the applicant are reviewed for compliance with applicable regulatory requirements
Collection and translation of the complete set of documents required for the registration dossier
Obtaining product samples (if required)
Development of a project roadmap
Assessment of project stages, complexity, and implementation timelines
Detailed budgeting of all project activities
02
STEP
Preparation of Submission Documents
04
STEP
Manufacturing Site Inspection
05
STEP
Specialized Expert Review
06
STEP
Laboratory Testing
07
STEP
Safety Assessment Report and Issuance of the Registration Certificate
03
STEP
Preliminary Expert Review
01
STEP
Project Analysis and Budget Planning
WORK PROCESS
! Important to Know: If a medical device differs from the information specified in the Registration Certificate (for example, if the manufacturer, composition, or instructions for use have changed), its distribution may be considered a regulatory violation. This may result in administrative liability and even suspension of the product's circulation on the market.
Therefore, before taking any action, contact us. We will advise you on the correct and risk-free course of action.
Medical device re-registration is required upon expiration of the state registration validity period. It is necessary to extend authorization for the circulation of the device within the Republic of Kazakhstan. The applicant must submit the relevant application and update the registration dossier in accordance with current regulatory requirements.
Amendments to the registration dossier are required when information related to the medical device is updated, including a change of manufacturer, modifications to composition, instructions for use, labeling, packaging, or other product characteristics. Such changes must be officially documented and approved by the competent authority.
Amendments are initiated by the holder of the Registration Certificate and may be planned or unplanned depending on the reason for the change. Without proper approval of amendments, the use or sale of a product with updated characteristics may be considered a regulatory violation.
RE-REGISTRATION AND AMENDMENTS
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66 Navoi Street,
Almaty, Kazakhstan
Almaty, Kazakhstan