Maintenance of medical equipment

2024

Roszdravnadzor published a checklist for licensing the maintenance of medical products

On January 24, 2024, the Federal Service for Supervision of Healthcare (Roszdravnadzor) announced an order to amend the form of an assessment sheet for licensing the maintenance of medical products. In accordance with it, an assessment of the compliance of the license applicant or licensee with the requirements in the implementation of this type of activity is carried out.

It is said that the supervisory authority excluded from the assessment list a clause that determines compliance with fire safety standards. According to the previous version of the document, the license applicant had to put a mark in the check list of Roszdravnadzor if he intends to carry out the service of medical equipment or store equipment for this in basements, attics, basement floors and ventilation shafts. Fire regulations prohibited the location of production facilities and the storage of equipment in specified places.

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In the new version of the checklist, the clause on compliance with fire safety standards is excluded. We are talking about the question "Does the license applicant, licensee use attics, technical, basement and basement floors, underground, ventilation chambers and other technical premises to carry out a licensed type of activity for the maintenance of medical devices."

It is noted that from September 1, 2024, the procedure for licensing activities for the maintenance of medical devices is being specified. The list of documents that the licensing authority requests from the license applicant during the assessment of compliance with the license requirements has been clarified; information that the license applicant for the maintenance of medical devices indicates in the application for the license; information that the licensee specifies in the application for changes to the license register.

Roszdravnadzor Order No. 9379 dated December 19, 2023

Roszdravnadzor canceled 2.5 thousand licenses for servicing medical equipment

On January 9, 2024, the Federal Service for Supervision of Healthcare (Roszdravnadzor) announced an order to cancel licenses for servicing medical equipment from more than 2.5 thousand companies. The reason is that these organizations did not re-issue permits until January 1, 2024 in accordance with the established requirements.

The order of Roszdravnadzor states that 2579 companies have their licenses for the maintenance of medical products terminated in accordance with sub-clause 8 of paragraph 13 of Article 20 of the Federal Law of 04.05.2011 No. 99-FZ "On Licensing Certain Types of Activities." The exception is if maintenance is carried out to ensure the own needs of a legal entity or individual entrepreneur, as well as cases of maintenance of medical devices with a low degree of potential risk of their use.

Roszdravnadzor announced an order to cancel licenses for servicing medical equipment from more than 2.5 thousand companies

According to the new rules, in order to obtain a license from market participants, it is necessary to determine the type of medical equipment, purchase/rent the necessary measuring equipment and introduce a quality management system according to a certain standard. In addition, the company must have a set number of engineers with the necessary qualifications. Thanks to the adoption of innovations for servicing 1-2 types of simple medical equipment, and often even medical furniture, which requires a minimum set of measuring instruments, equipment and competencies from specialists, a license does not need to be obtained.

Roszdravnadzor reported that the bulk of organizations actually working in the field under consideration managed to reissue licenses. At the same time, according to the agency, the withdrawal from the market of companies that have not reissued the license in accordance with the requirement of the law "will not affect the quality and timeliness of maintenance and repair of medical equipment."^[1]

2023: Mishustin exempted medical equipment manufacturers from licensing requirements for equipment maintenance

Prime Minister Mikhail Mishustin signed a decree that exempted manufacturers of medical equipment from licensing requirements for the maintenance of equipment. The corresponding document was published on the official portal of legal acts on August 15, 2023.

According to the amendments made, periodic scheduled and unscheduled maintenance, as well as repair and dismantling, have been introduced into the list of the concept of "maintenance," which falls under licensing.

Mikhail Mishustin

Manufacturers or authorized persons of foreign manufacturers who are engaged in the service of their brand equipment and are indicated in the regional inspection will be exempted from part of the licensing requirements, including the requirement of the quality management system and the availability of equipment and measuring instruments from the list.

In addition, the lists of equipment for the maintenance of medical devices of potential risk class 2a and 2b have been supplemented. They include cardiovascular medical products, medical devices for obstetrics and gynecology, urological medical devices, radiological medical devices, including ultrasound scanners, magnetic resonance tomographs, products for plastic surgery, dermatology and cosmetology, ophthalmology, physiotherapy, as well as medical equipment for apheresis.

It will be possible to apply for a license, as well as make changes to it through the portal of public services, and in terms of changing the name of work or services provided, Roszdravnadzor will not assess the company's compliance with licensing requirements.

The changes will take effect on September 1, 2024.

Earlier, the government approved a new regulation on licensing the maintenance of medical devices. From under the regulation of the document, the service of medical devices with a low risk class, as well as legal entities or individual entrepreneurs engaged in servicing their own medical equipment, was removed.

Government of the Russian Federation Resolution of August 12, 2023 No. 1332

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