Order of the Minister of Health of the Republic of Kazakhstan dated DSM-129 amended the Rules of Medical Devices Classification depending on the degree of potential risk of use. The Rules apply to medical devices manufactured and imported on the territory of the Republic of Kazakhstan.
Depending on the degree of potential risk of use, medical devices have been divided into 4 classes: 1, 2a, 2b and 3.
In accordance with the approved document, the applicant, shouldindicate the risk class of medical device depending on the degree of potential risk of use in an application to the State Expert Center. The State Expert Сenter assess the credibility of the class indicated by the applicant and may determine a class that is different from the one chosen by the applicant.
Each medical device belongs to one single class.
Classification of medical devices is based on the following:
- Class 1 includes medical devices with a low potential risk of use;
- Class 2а includes medical devices with medium potential risk of use;
- Class 2b includes medical devices with an increased potential risk of use;
- Class 3 includes medical devices with a high potential risk of use.
The classification of a medical device takes into account its intended use and conditions of use, as well as the following criteria:
- duration of use of the medical device;
- invasiveness of the medical device;
- presence of contact or relationship between the medical device and a human tissues/organs;
- method of placing a medical device into body (through a body orifice or surgically);
- use of a medical device for vital organs and systems (heart, central circulatory system, central nervous system);
- use with energy sources.
This order shall come into force upon the expiration of ten calendar days after the day of its first official publication on October 2, 2019.
https://gmpnews.ru/2019/10/kazaxstan-izmenil-pravila-klassifikacii-medicinskix-izdelij/