Pilot project on digital labeling of medical products is about to start

The Ministry of Industry and Trade of the Russian Federation  has proposed to conduct an experiment in the field of digital labeling of certain types of medical devices in order to test the mechanism of the labeling system in the fight against illegal import, production and trade of such products.

Digital labeling of various product groups

The national system of digital marking and tracking of goods has been created and is working successfully - informed the representative of the Center for Advanced Technologies Development. 15 groups of goods are already labeled in compulsory or pilot procedures - from medicines and cigarettes to fur and bicycles. Over 6 billion codes are tracked in the system. This system is ready to scale up a project for medical devices.

Which products are included in the pilot project?

After discussions and consultations with the medical community and manufacturers of medical devices, it was considered necessary to include in the pilot project such categories of medical devices as:

  • hearing aids
  • coronary stents
  • orthopedic shoes
  • corrective elements for orthopedic products
  • absorbent products for personal health and hygiene

Executive bodies of the program

The executive bodies authorized to ensure that the experiment is conducted appropriately are the Ministry of Industry and Trade, the Ministry of Health, the Ministry of Finance, The Ministry of Digital Development, Communications and Mass Media, the Federal Service for Surveillance in Healthcare, the Ministry of Economic Development, and the Federal Customs Service. The discussed experiment may start as early as August 1 this year.

Changes in the conformity assessment of medical products

We would like to remind you that from January 2021 the entire list of medical devices was excluded from the list of products subject to mandatory conformity assessment. The decision was made as part of the implementation of the "regulatory guillotine" - a mechanism to eliminate duplicate or outdated requirements.