Mandatory labelling of medical devices in Russian Federation from 2023

Mandatory labeling of medical devices and medical products with an additional information code has been introduced in Russian Federation. According to the labeling established by current standards. It must be displayed as special characters.

The need to display Data Matrix codes on products, packaging and labels is due to a number of advantages. First of all, it is an opportunity to control the movement of a product unit from the moment of production to sale and write-off. Also, due to the use of barcode it is possible to exclude the presence of counterfeit products on the market and provide the opportunity for medical organisations to work with quality equipment and materials. In addition, labelling gives a guarantee to the buyer that he is buying a product that will not cause harm to the body.

Specialists of UCEC «QUALITY» LLC have been working for a long time in the field of preparation of documentation for registration procedures. We keep track of all changes and innovations in legislation, which gives high chances of successful completion of all stages of registration in the Honest Mark labelling system. Thanks to competent legal support from our employees, you will have an opportunity to significantly facilitate the process of mandatory labelling of certain goods intended for health purposes.

Further in the article we will consider the terms of labelling, the algorithm of actions and the types of products subject to mandatory barcodes.

Table of contents:

1. Labelling of medical devices from 2023
2. Law on labelling of medical devices in Russia
3. Mandatory labelling of medical devices with means of identification
4. DataMatrix digital code
5. Whose responsibility is it to label medical devices?
6. Timing and procedure for introducing mandatory labelling of medical devices

Labelling of medical devices from 2023

From 2023, labelling of medical devices is among the mandatory procedures in Russia. Its introduction is carried out in several stages, which ensures the possibility of adaptation and proper preparation for all participants in the turnover.

In general, the implementation of labelled products is characterised by increased complexity. For this purpose, it is necessary to record each stage in the Honest Mark system, as well as to reflect it in product accounting.

It is more comfortable to carry out activities in one place. Inform about the withdrawal of codes from circulation; perform the exchange of documentation with organisations involved in the supply of products via electronic document management (EDI); accept information on profits and balances. All this is possible with the help of the trade automation programme MojSklad. Through it it is possible to keep records of different products. At the same time, there is a CRM and a cashier’s place in the package. Round-the-clock support, a free tariff and a quick start are provided.

Law on labelling of medical devices in Russia

From 1 September 2023, labelling of medical devices becomes a mandatory procedure, in accordance with Russian Government Decree No. 894. The document makes it possible to control the work of all participants: manufacturers, importers and retail sellers.