Restrictions on admitting new types of medical devices to state and municipal procurement

Previously, through its Resolution No. 102 dated 5 February 2015, the Russian Government approved a list of individual types of medical devices originating in foreign countries the admission of which is restricted for the purposes of procurement for state and municipal needs (for more detail, see our information bulletin (alert) dated 11 February 2015).

We remind you that the restrictions apply to all bids containing offers to supply medical devices originating in foreign countries, except for EAEU member states. The customers will reject such bids if at least two bids have been placed in the process of identifying a supplier which are consistent with the requirements of the procurement documentation and at the same time:

• contain proposals to supply individual types of medical devices included in the list and originating from member states of the Eurasian Economic Union;
• do not contain proposals to supply the same type of medical devices from the same manufacturer or manufacturers included in one group of entities which meets the criteria set out in article 9 of the Federal Law 'On protecting competition’, when such bids (final proposals) are compared.

Now, the list of medical devices has been updated with 62 items. For instance, the following items have been added:

• diagnostic equipment, including X-ray generators,
• physiotherapeutic equipment,
• diagnostic sets,
• surgical and dental instruments,
• rehabilitation equipment,
• intensive care incubators for newborn babies,
• medical devices from the cotton gauze group,
• absorbent linen, etc.

The full list is set out in the Appendix to this alert.

It is reported that the medical devices included in the list are produced by no less than two Russian entities in compliance with inter-state standard GOST ISO 13485-2011 “Medical devices. Quality management systems. System requirements for the purposes of the regulation”.

The Resolution was adopted in pursuance of the Roadmap of the Russian Government aimed at ensuring the steady social and economic development of the Russian Federation in 2016 (dated 1 March 2016 No. 1349p-P13). The decision made is to contribute to the development of import substitution projects and enhance Russian production of medical devices.

Coming into force

The Resolution will come into force 7 days after it is officially published for the first time. At the time of writing, the Resolution had not yet been published as required by the procedure defined in the Russian President's Order No. 763 dated 23 May 1996 (in the version of it dated 14 January 2014).

What to think about

In connection with the above innovations, we recommend that companies whose products are now included in the above list analyse their current market strategy.

After the changes come into force, such products will be subject to the so-called ‘three is too many’ rule, which may significantly affect the competitive environment.

Companies wishing to retain or increase their market share should pay attention to such options as localising production, including by using the tool of special investment or regional investment contracts.

Help from your advisers

Pepeliaev Group's lawyers have significant experience in providing advice to and representing clients in matters connected with the procurement of medical devices. They stand ready to provide comprehensive assistance and legal support on these matters in connection with the developments discussed above. This may include preparing legal advice and documents, representing companies in procurement-related disputes as well as providing assistance for projects related to the localisation of medical devices.