June 1, 2023
Description of Resolution No. 894 dated 05/31/2023
According to the Resolution of the Government of the Russian Federation No. 894 of 31.05.2023, the Rules for labeling certain types of medical devices with identification devices are approved.
This resolution establishes that participants in the turnover of certain types of medical devices submit to the state information system for monitoring the turnover of goods subject to mandatory labeling by means of identification, an application for their registration in the monitoring information system starting from 01.09.2023. Participants in the turnover of certain types of medical products that have a valid registration certificate for a medical product put identification tools on consumer packaging, including by applying a label containing an identification tool on consumer packaging.
Which medical devices are subject to mandatory labeling:
|
OKPD code 2 |
Product name |
Code of the type of medical device in accordance with the nomenclature classification of medical devices |
|
28.25.14.110 |
Decontaminators-air purifiers (including equipment, bactericidal installations and recirculators used for filtering and purifying indoor air) |
131980, 152690, 152700, 182750, 209360, 292620 |
|
32.50.22.150 |
Orthopedic shoes and removable corrective elements for orthopedic shoes (including insole, half-insole) |
250220, 250230, 250250, 250260, 320560, 343610 |
|
26.60.14.120 |
Hearing aids, other than parts and accessories |
113850, 173110, 202800, 202810, 204370, 210000, 228560, 302870 |
|
32.50.22.190 32.50.22.195 |
stents |
135820, 155760, 155800, 155820, 218190, 273880, 343410, 343540 |
|
26.60.11.111 |
Computer tomographs |
135190, 142570, 280730, 282030 |
|
17.22.12.130 |
Sanitary and hygienic products used for incontinence |
233730, 233900, 280360, 320550, 331320, 331330, 331830, 356150 |
The digital product labeling system is based on digital code technology using the DataMatrix standard (Figure 1), which stores information about each product unit, as well as cryptographic protection technology that ensures that the code cannot be forged. A unique code is applied to each product unit in production or during import (for individual product groups)
Figure 1-Sample DataMatrix code
The tag code stores the following information:
1) Product code GTIN consisting of 14 digits;
2) Individual serial number of 13 characters;
3) Verification code, which provides verification of the originality of the marking code.
To apply the code on the label or lid, a small surface area of approximately 13×13 mm is required. The exact size and location of the application can be determined after conducting experimental work at the enterprise. The cost of the service for traceability of marked goods (generating and providing a code/storing information about the transfer of the marking code betweenlegal entities per unit of goods) is approved by Decree of the Government of the Russian Federation No. 577 of May 8, 2019, is 50 kopecks excluding VAT and is fixed for 15 years.
