The Government of the Russian Federation decided to amend Decree No. 2129 dated November 30, 2021, which establishes the procedure for licensing activities for the maintenance of medical devices. Document No. 1332, signed on August 12, 2023, will enter into force on September 1 next year.
The innovations concerned the rules for making changes to the registry when changing the name of the type of maintenance work. To do this, Roszdravnadzor no longer needs to assess the manufacturer’s compliance with licensing requirements.
The procedure for obtaining a license to carry out maintenance activities has been simplified. To obtain a license, it is necessary to submit only an electronic application on the Unified Portal of Public Services of the Russian Federation using data from the Unified Identification and Authentication System and the Unified Register of Licenses.
The application must contain the following information:
Information on the implementation of the GOST ISO 13485-2017 quality management system is not required. At the same time, when checking the assessment of the applicant’s compliance with licensing requirements, carried out before obtaining a license, confirmation of the availability of a QMS is mandatory.
The application is signed with an enhanced unqualified electronic signature if it is submitted by a legal entity and by an electronic signature – from an individual. The terms for considering and making a decision on issuing a license have been reduced from fifteen to ten days.
Also, manufacturers and their authorized representatives, in the event that they independently carry out maintenance of their products, are not required to use special measuring instruments and equipment that are provided for various types of medical equipment.
In addition, the Regulation on Licensing Activities for the Maintenance of Medical Devices has been updated (Appendix No. 2). Products for urology, radiology, obstetrics and gynecology have been added to the section “Potential risk class 2a”. The changes also affected Annex No. 1, where products for otorhinolaryngology and neurology, auxiliary and general hospital products were added.