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Kazakhstan Medical Device Regulations

Regulatory Agency

The National Center for Expertise of Medicines and Medical Devices (NDDA) regulates medical devices in Kazakhstan

Medical Device Definition

Medical Devices: any instrument, device, equipment, material, product, except products of human origin, or other item used alone or in combination, including accessories and software involved in its operation, intended by the manufacturer to be used in humans for medical purposes and whose desired main action is not obtained by pharmacological or immunological means or by metabolism, but whose function can be assisted by such means.

Invasive Medical Device: medical devices intended for complete or partial introduction into the human body through its surface or through an opening in the body.

Active Medical Device: medical devices used alone or in combination with other medical devices that require energy other than that produced by humans or gravity to operate. Medical devices designed to transfer energy or substances from an active medical device to a patient without their significant modification, are not active medical devices. Independent software is considered as active medical device.

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

Regulatory Approval Process

Classification

Approval procedure

Class 1

 

 

 

 

 

Class 2a

 

 

 

 

 

Class 2b

 

 

 

 

 

Class 3
  • The applicant, when submitting to the state expert organization the application and documents, indicates the class of medical device depending on the degree of potential risk of use.
  • The state expert organization carries out an assessment of the reliability the class of medical device specified by the applicant, depending on the degree potential risk of use.
  • The state expert organization determines another class medical device depending on the degree of potential risk of use, different from that declared by the applicant, in the following cases:
  1. obtaining additional information about the occurrence of a possible hazard based on a review of modern scientific data when using (operating) medical devices;
  2. obtaining additional information regarding the area use of medical devices;
  3. the presence of data on harm to health or life associated with technical or medical reasons that do not ensure the safety of the consumer.
  • The authorized body in the field of health care in accordance with the procedure provided for in paragraph 1 of Article 71 of the Code, upon state registration of a medical device, the class of the medical device is approved depending on the degree of potential risk of use.

Additional Information

Approval timeline

Not specified by the agency

License validity period

5 years (medical devices) 7 years (medical equipment)

Fees:

Service type Examination of Products Fees (KZT)
Expert assessment of the optimal technical charachteristics of te medical 1 examination 69,500
Expert assessment of the clinical and technical justification of the medical product 1 examination 69,500
Assessment of the quality of medicines and medical devices by declaration/expertise of the document 1 Product 10,983

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