Article 258. Classification of safety and reclassification of safety of medical devices depending on the degree of potential risk of application of the Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. Medical devices used in the Republic of Kazakhstan are divided into classes depending on the degree of potential risk of use and types in accordance with the nomenclature of medical devices of the Republic of Kazakhstan.
2. The rules for classifying medical devices depending on the degree of potential risk of use are approved by the authorized body.
3. The class of medical devices according to the degree of potential risk of use is approved by the authorized body upon state registration. Each medical device can be assigned to only one class.
4. The procedure for the formation and maintenance of the nomenclature of medical products of the Republic of Kazakhstan is determined by the authorized body.
5. The authorized body may make changes to the classification based on a detailed consideration of the principles, phenomena, and medical techniques underlying the operation of medical devices.
President
Republic of Kazakhstan
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