The National Center for Expertise of Medicines and Medical Devices (NDDA) regulates medical devices in Kazakhstan.
Medical Device Definition
A medical device in Kazakhstan is any materials, products, solutions, reagents, or kits used to provide medical care. Whereas medical equipment is any device, equipment, and complex 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 Device Classification System
|Class 1||Low risk||Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale|
|Class 2a||Low–moderate risk||Pregnancy self-testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask|
|Class 2b||High- Moderate risk||Blood glucose self-testing, ECG, X-ray Unit, Syringe, Condom, Contact lens|
|Class 3||High risk||HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker|
|Approval timeline||4 to 10 months approximate|
|License validity period||5 years (medical devices)
7 years (medical equipment)|
|Fees||In range of 48,000 KZT per unit- 577,000 KZT|