Mandatory labelling requirements for medical devices

According to a Decree of the Government of the Russian Federation No. 894, dated 31 May, 2023, the Rules are set out for the labelling of certain types of medical devices using identification means.

This Decree establishes that the parties involved in the circulation of certain types of medical devices shall submit an application to the State Information System for the Monitoring of Circulation of Goods Subject to Mandatory Labelling Using Identification Means, in order to register their related goods in the Information System, starting from 1 September, 2023. The parties involved in the circulation of specific types of medical devices, which already have registration certificates issued for such medical devices, shall apply identification means to the secondary packaging, which includes application of the label containing identification means to the secondary packaging.

Medical devices that are subject to mandatory labelling are the following:

OKPD 2 code Name of the goods Code of the type of the medical device in accordance with the nomenclature classification of medical devices
Air cleaning and disinfection devices (including equipment, bactericide treatment units and recirculation units used for air indoor air filtration and cleaning) 131980, 152690, 152700, 182750, 209360, 292620
Orthopaedic footwear, and corrective inlays for orthopaedic footwear (including insoles and half socks) 250220, 250230, 250250, 250260, 320560, 343610 Hearing aids, except parts and accessories 113850, 173110, 202800, 202810, 204370, 210000, 228560, 302870
Coronary stents 135820, 155760, 155800, 155820, 218190, 273880, 343410, 343540
Computer assisted tomography units 135190, 142570, 280730, 282030 Sanitary and hygienic items used for inconsistency 233730, 233900, 280360, 320550, 331320, 331330, 331830, 356150

The digital labelling system is based on digital code technology, in which the DataMatrix standard is employed (see Figure 1); this code contains information about each goods item, and is protected by crypto-security technologies to ensure that the code cannot be forged/manipulated. This Unique code has to be applied to every goods item concerned during manufacturing or import (for certain groups of goods).

Figure 1 — Example of the DataMatrix code

The labelling code contains the following information:

1) GTIN code, 14 characters;

2) Individual serial number of the goods item, 13 characters;

3) Control code to ensure integrity of the labelling code.

For the label itself, a small area of packaging is required, approx. 13 x 13 mm. The exact size and location shall be determined after factory tests. The cost of traceability of the labelled goods (generation and provision of code/storage of information regarding labelling code transfer between legal entities, per item of goods) is set and approved by a Decree of the Government of the Russian Federation, no. 577, dated 8 May, 2019, and is equal to 50 kopecks (excl. VAT); this value is fixed for 15 years.