Medical Device Maintenance Licensing Rules 2023

In August 2023, Government Decree (GD) No. 1332 was published, containing information on changes to the Regulation on Maintenance Licensing (ML) of Medical Devices (GD No. 2129 of 11/30/2021).

After the entry into force of the GD (September 1, 2024), Roszdravnadzor will have the opportunity to make changes to the register related to changing the name of the work performed / services provided without assessing the compliance of the company or individual entrepreneur with license requirements, as well as submitting an application for changes.

In addition, the decree contains a number of simplifications for manufacturers and their authorized representatives to obtain a license. In particular, if organizations maintain their own products, they will not need to have the measuring instruments and equipment provided for certain categories of medical devices.

To obtain a maintenance license, the applicant only needs to submit an application in electronic form in his personal account on the public services portal.

In the application, in addition to the details provided for in Part 1 of Art. 13 of the Federal Law “On licensing certain types of activities” (name of the legal entity, Tax ID, licensed type of activity, documents specific to a particular licensed type of activity) must be provided:

  1. Details of documents confirming the ownership of the buildings/premises where maintenance is planned to be carried out;
  2. Confirmation of the availability of equipment and measuring instruments necessary for maintenance;
  3. Data of documents on the education of employees;

Information about the implementation by the applicant of a quality management system (QMS) GOST ISO 13485-2017 is no longer required. However, it will be necessary to confirm the availability of the QMS during the pre-licensing check of the applicant’s compliance with the licensing requirements.

The licensing authority will make a decision on issuing a license within 10 business days (instead of 15).

The Decree of the Government also introduces changes to Annexes 1 and 2 on licensing activities for the maintenance of medical devices:

  1. Appendix 1 (List of work performed, services provided as part of the maintenance of medical devices): new types of medical devices have been added – auxiliary and general hospital, neurological and otolaryngological devices.
  2. Appendix 2 (List of measuring instruments, technical means and equipment necessary for the maintenance of the declared groups of medical devices according to the classes of potential risk of their use): urological and radiological MD, as well as MD for obstetrics and gynecology appeared in the MD risk class 2a section.

References:

  1. https://pharmvestnik.ru/content/news/Pravitelstvo-obnovilo-pravila-licenzirovaniya-tehobslujivaniya-medizdelii.html
  2. https://www.consultant.ru/document/cons_doc_LAW_454755/92d969e26a4326c5d02fa79b8f9cf4994ee5633b/
  3. https://www.consultant.ru/document/cons_doc_LAW_113658/