ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 15, 2020 No. 1445

About approval of the Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application)

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application).

2. The licenses for activities on production and maintenance (except for case, if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment issued before entry into force of this resolution are subject to renewal according to requirements of the Provision approved by this resolution till December 31, 2023.

3. To the Federal Service on supervision in the field of health care till July 1, 2021 to staticize data of register entries of the unified register of the licenses containing data on production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment which according to the Provision approved by this resolution do not require receipt of the license.

4. This resolution becomes effective since January 1, 2021 and is effective till January 1, 2027.

Approved by the Order of the Government of the Russian Federation of September 15, 2020 No. 1445

Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application)

1. This Provision determines procedure for licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application).

2. The licensed activities for maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also except for case of maintenance of medical products with low degree of potential risk of their application) medical products represent periodic and unplanned technical diagnosing, maintenance, installation and adjustment of medical products from groups on classes of potential risk of their application according to appendix for which these works are provided by regulating, technical or operational documentation of the producer.

If for medical product regulating, technical or operational documentation of the producer does not provide actions for periodic and unplanned technical diagnosing, maintenance, installation and adjustment or it cannot be carried to one of groups of medical products according to class of potential risk of their application according to appendix, activities for maintenance of working capacity or operability of such medical products are not subject to licensing.

3. The structure of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application) (further - activities for maintenance of medical products) includes works (service) in the list according to appendix.

4. Licensing of activities for maintenance of medical products is performed by the Federal Service on supervision in the field of health care (further - the licensing body).

The licensing body approves document forms, necessary for realization of this provision (forms of the submitted applications, notifications and data).

5. Licensed requirements when implementing activities for maintenance of medical products are:

a) availability at the license applicant:

belonging to it on the property right or on other legal cause of the rooms, buildings, constructions in the place of implementation of the licensed type of activity necessary for implementation of activities for maintenance of medical products;

paragraphs 3 - 9 voided

the measuring instruments conforming to requirements to their checking, the stipulated in Article 13 Federal Laws "About Ensuring Unity of Measurements", the technical means and the equipment necessary for maintenance of the declared groups of medical products on classes of potential risk of application according to the list approved by the Ministry of Health of the Russian Federation;

the operational documentation of the producer of medical products necessary for maintenance of the declared groups of medical products on classes of potential risk of application;

the quality management system created and functioning according to requirements of the state standard specification ISO 13485-2017 interstate standard;

the workers (in case of accomplishment of 1 or 2 work types (services) - at least 2 people, in case of accomplishment of 3 or 4 work types (services) - at least 3 people, in case of accomplishment of 5 and more work types (services) - at least 5 people) who signed employment contracts with the license applicant, performing maintenance of the medical products having the higher or secondary professional (technical) education, length of service in at least 3 years and additional professional education (advanced training at least once in 5 years) in the field of the performed works and the rendered services;

b) for the licensee:

availability belonging to the licensee on the property right or on other legal cause of the rooms, buildings, constructions in the place of implementation of the licensed type of activity necessary for implementation of activities for maintenance of medical products;

paragraphs 3 - 9 voided

availability belonging to the licensee on the property right or on other legal cause of the measuring instruments provided by regulating, technical documentation and conforming to requirements to their checking, the stipulated in Article 13 Federal Laws "About Ensuring Unity of Measurements", the technical means and the equipment necessary for maintenance of the declared groups of medical products on classes of potential risk of application according to nomenclature classification of medical products by classes depending on potential risk of their application;

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