It is not necessary to obtain a license for the maintenance of equipment used for the personal needs of a legal entity or individual entrepreneur, or for the maintenance of medical devices with a low degree of risk of their use. In this case, it is essential to comply with stipulations set forth in Federal Law 2300-1, dated 7 February 1992. It is the responsibility of the manufacturer to ensure that all medical and other equipment is maintained throughout the guaranteed service life.
Manufacturer's Responsibilities for Medical Equipment Maintenance
- Monitor equipment performance, carry out periodic and unscheduled maintenance of equipment as required;
- Diagnose equipment, checking the reliability and safety of the equipment;
- Perform repairs in a timely manner;
- The manufacturer installs and adjusts the equipment himself and dismantles it as necessary;
- The manufacturer is responsible for the serviceability, safety and performance of the equipment produced.
The license permits the maintenance processes to be carried out directly.
Documents Required for the Acquisition of a License for the Maintenance of Medical Devices
Submit your license application together with necessary data electronically using the personal account on the Gosuslugi (State Services) portal. Apart from the application, the submission of other documents is not required, unless they cannot be received by the licensing authority in electronic form.
The data on the information required for the application are specified in p. 1-4 of part 1 of Art. 13 of the Federal Law ‘On Licensing of Certain Types of Activities’ in addition to which the following documents shall be submitted:
- Documented ownership rights or other grounds confirming the right to use the premises for the implementation of the process of maintenance of medical devices;
- Documented rights of ownership or other grounds for the right to use measuring instruments, as well as technical means and equipment provided for the organization of activities for the maintenance of medical devices;
- Operational documentation. Copies of documents required for technical maintenance of medical devices by potential risk classes of use.
- The applicant needs to confirm the availability of systems that are used for quality control. In addition, documents confirming the existence of a quality management system license compliant with GOST ISO13485-2017 are also required.
- Necessary copies of documents of employees who carry out medical equipment maintenance activities. Namely: availability of education (higher or secondary technical education), employment contracts, licenses to perform certain activities, documents on work experience of at least 3 years, as well as on completion of refresher training at least once every 5 years.
- The application can be signed with an enhanced non-qualified electronic signature (for legal entities and individual entrepreneurs) or just an electronic signature (for individuals).
Timeframe for Obtaining a License
- Roszdravnadzor must take a final decision on granting or refusing to grant a license but no later than 10 working days after receipt of the application via the Gosuslugi portal.
- Making changes does not exceed 5 working days from the date of receipt of the application via the Gosuslugi portal.
* When carrying out activities on the territory of a closed administrative-territorial entity, the terms differ.
Preparation and Submission of Documentation Package
At MedReg Consulting, our specialists provide comprehensive support throughout the licensing process. They submit the necessary documents for review, oversee the decision-making process, facilitate the issuance of the license, and deliver it to the customer.
Therefore, in order to obtain a license for the maintenance of equipment, it is necessary to prepare a package of documents and submit an application to Roszdravnadzor for review. A written and electronic response will be provided.