Trademark

When registering a medical device (MD) within the framework of Resolution No. 1416 dated December 27, 2012 "On Approval of the Rules for State Registration of medical devices" and the presence of a trademark in the name (and/or labeling), Roszdravnadzor verifies the legality of the manufacturer's use of the trademark (TM) for a medical device.

Reference:
Manufacturers can use signs to indicate TM:
TM sign (trademark) - Usually the ™ sign is applied at the moment when the trademark registration application has already been filed with the patent office, but there is no TM registration yet. It has no legal force in the Russian Federation and has not found application.

R in a circle® - is a warning sign that is applied if the name is registered as a trademark in the territory of the Russian Federation. It is not mandatory.

Trademarks in Russia are registered with Rospatent, you can check the registration and find the copyright holder on the website https://searchplatform.rospatent.gov.ru/trademarks.

Example of a registered trademark:

If the manufacturer of a medical device is not the copyright holder and uses TM on a medical device, then the Rospatent registry entry should indicate who has the right to use TM, an example of an entry:

This entry is made on the basis of a license agreement for the right to use TM and an application for registration of the right to use in Rospatent.

Therefore, if this entry is not available, then as part of the registration dossier it is necessary to provide documents confirming the right to use TM by the manufacturer and that changes will be made to the Rospatent register:

- License agreement for the right to use TM (concluded between the copyright holder and the company that will use this TM);

- Notification of registration of the right of use in Rospatent.

In the absence of the specified entry in the register or documents in the registration dossier, Roszdravnadzor will make a remark, for example:

The name of the medical device, as well as the photographic images of the packaging and labeling of the medical device contain the trademark ---- ®, while the registration dossier does not contain information confirming the right to use these marks on the territory of the Russian Federation by the manufacturer of the medical device.