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MAINTENANCE AND REPAIR PERMISSION ISSUED BY MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

Maintenance and repair of medical devices is a set of operations and organizational actions to restore the serviceability, operability and resource of medical equipment or its components according to the technical and (or) operational documentation of the manufacturer and the technical regulatory legal act during its use, storage and transportation in to ensure its safe and efficient operation.

Maintenance and repair of medical devices is part of the circulation of medical devices.

Procedure

From 03.07.2020, for the provision of services and performance of maintenance and repair of medical equipment in the Republic of Belarus, a Conclusion on the possibility of carrying out work (services) for the installation, adjustment, maintenance and repair of medical equipment and medical products is required.

 

The opinion is issued by the authorized body based on the results of the administrative procedure in accordance with the unified list of administrative procedures carried out by state bodies and other organizations in relation to legal entities and individual entrepreneurs (approved by the resolution of the Council of Ministers of the Republic of Belarus dated 17.02.2012 No. 156).

 

Technical work on preparation for the issuance of an opinion on the possibility of carrying out work (services) for the installation, adjustment, maintenance and repair of medical equipment and medical products is carried out by the "Research Center for Examinations and Tests in Health Service" Republican Unitary Enterprise.

Scope of provided services

  • collection and preparation of a set of documents for the implementation of the administrative procedure to the authorized body;

  • translation of documents into Russian according with the requirements of the legislation;

  • obtaining an appropriate conclusion.

AVAKO is ready to help in going through all the stages of the process of obtaining an opinion on the possibility of carrying out work (services) for the installation, commissioning, maintenance and repair of medical equipment and medical products.

 

Our specialists have extensive experience in obtaining appropriate opinions on a wide range of medical devices and can you with qualified assistance in compliance with the applicable law as soon as possible.

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