Document from CIS Legislation database © 2003-2020 SojuzPravoInform LLC

ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 15, 2020 No. 1445

About approval of the Regulations on licensing of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment

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 production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment.

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.

Russian Prime Minister

M. Mishustin

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

Regulations on licensing of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment

1. This Provision determines procedure for licensing of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment.

2. The concepts used in this Provision mean the following:

"maintenance of medical equipment" - complex of the actions for the maintenance of operability and (or) maintenance of medical products with monitoring procedure of technical condition in case of their proper use provided by the producer regulated by operational documentation of the producer of medical product and also action for installation and adjustment of medical products;

"medical equipment" - the medical products (except for 1 class of potential risk of application) which are subject to maintenance and representing the tools, devices, devices, the equipment used in the medical purposes separately or in combination, and also together with other accessories necessary for application of the specified products to destination, including the special software, and intended by the producer for prevention, diagnostics, treatment and medical rehabilitation of diseases, monitoring of condition of human body, carrying out medical researches, recovery, substitution, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy which functional purpose is not implemented by pharmacological, immunological, genetic or metabolic impact on human body.

3. The structure of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment (further - activities for production and maintenance of medical equipment) includes works (service) in the list according to appendix.

4. Licensing of activities for production and maintenance of medical equipment 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 production and maintenance of medical equipment are:

a) for the license applicant:

availability belonging to the license applicant 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 production and maintenance of medical equipment;

availability at the license applicant having intention to perform activities for production of medical equipment:

the measuring instruments provided by regulating, technical documentation of the producer 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 implementation of activities for production of medical equipment;

the registration certificate on medical equipment, confirmatory that the license applicant performs production of this medical equipment or is related to production site of this medical equipment provided that the producer (the authorized representative of the producer) signed the agreement with the license applicant on production organization regulating including questions of ensuring quality control and safety of the made products, and also responsibility to the third parties;

the regulating, technical documentation used for implementation of activities for production of medical equipment;

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

the workers who signed employment contracts with the license applicant responsible for production and the quality of medical equipment 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;

availability at the license applicant having intention to perform activities for maintenance of medical equipment:

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 equipment on classes of potential risk of application according to the list approved by the Ministry of Health of the Russian Federation;

operational documentation of the producer of the medical equipment necessary for maintenance of the declared groups of medical equipment 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;

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 40000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.