Registration of medical equipment

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.

Medical devices include medical devices and medical equipment;

Medical devices - materials, products, solutions, reagents, kits, kits used to provide medical assistance in accordance with the functional purpose and manufacturer's instructions;

Medical equipment - appliances, devices, equipment, complexes, systems used separately or in combination with each other to provide medical care in accordance with the functional purpose and performance characteristics established by the manufacturer;

Medical products for in vitro diagnostics - any instruments, devices, appliances, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes separately or in combination with each other, as well as together with the accessories necessary for use of the specified products for the intended purpose, including special software, and samples of human biological materials intended by the medical device manufacturer for in vitro studies use to obtain information regarding the physiological or pathological condition, congenital pathology, predisposition to a specific clinical condition or disease, tissue compatibility with a potential recipient, predicting responses to therapeutic interventions, choosing therapeutic agents and (or) for monitoring of treatment.

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;

We offer

• Free consultation by the highly qualified professionals;
• Individual approach to every customer;
• The minimum possible registration terms;
• Provision of services in accordance with the current legislation of the Republic of Kazakhstan and the EAEU;
• A systematic approach based on proven procedures for all processes in accordance with ISO:9001-2015;
• Comprehensive approach to file management;
• Confidentiality of information, compliance with professional and ethical standards.