Implementing Service Maintenance of Medical Devices

The Order of the RoK Minister of Health No.ҚR DSM-273/2020 "On Approval of the Rules for Implementing Service Maintenance of Medical Devices in the Republic of Kazakhstan" was adopted on December 15, 2020.

These Rules replaced the previous Rules for the Implementation of Medical Equipment Maintenance in the Republic of Kazakhstan, approved by the Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated May 29, 2015, No. 427.

It worth mentioning that the new Rules word-for-word repeat the provisions of the old Rules. However, there are some differences, which are highlighted below for your convenience:  

1. The new Rules stipulate requirements for servicing medical equipment. Thus, the contradiction that arose after adopting the new Health Code was eliminated, according to which medical devices were divided into medical equipment and medical devices. The old Rules did not take this fact into account.

2. Some definitions did not carry over from the old Rules, which is due to various reasons. In particular, the definition of "check-out technical tests" was most likely excluded due to its uselessness (it was not used already in the old Rules). Another definition - "owner of a medical device", which previously meant only health care entities, has been eliminated most likely because the new Rules took into account that the owner of medical equipment can be a health care entity, as well as other individuals and legal entities.

3. The new Rules have added additional requirements for service providers. So, to carry out service work, a person is required to provide: (i) a certificate of the existence of a valid quality management system following GOST ISO 9001 or GOST ISO 13485, (ii) valid technical and operational documentation of the manufacturer (manufacturer).

4. According to the new Rules, when monitoring the technical condition of medical equipment, in addition to making an entry in the technical condition log about detected inconsistencies or breakdowns and notifying the service functions, the provision of the report is also required.

5. If necessary, during the periodic inspection of medical equipment, it is allowed to replace spare parts, instruments, accessories, and consumable instruments.

6. As per new Rules - the health care entity has the right to terminate the maintenance service and to decide on the impossibility to perform repair work, following which the medical equipment must be utilized.

7. The provision on periodic monitoring of the technical condition during the service warranty period (must be carried out at least once a year) remains. However, the manufacturer can set a different frequency (but my understanding: it is applicable in cases where the manufacturer specifies more frequent controls).