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Kazakhstan Medical Device Regulations

Agency
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
Classification Risk Level Examples
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 Process
Classification Approval procedure
Class 1
  • An application for an examination.
  • Submission of the registration dossier.
  • Submit the general technical documents via a state expert organization with the applicable fee.
  • Declaration of conformity with the requirements for the safety and efficacy of a medical device.
  • Quality management system of the manufacturer of medical devices ISO 13485, GMP, or the relevant regional or national standards are required to be fulfilled.
  • Completion of the requirement by the applicant.
  • Issuance of the approval certificate.
Class 2a
Class 2b
Class 3
Additional Information
Approval timeline 4 to 10 months approximate
License validity period 5 years (medical devices) 7 years (medical equipment)
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