Is packaging for medicines a medical device?

Registering medicines is a complex process, often requiring the registrar to be knowledgeable not only of the relevant regulatory documents but also of related documents. One of the most challenging aspects of the registrar's work has long been the classification of drug packaging as medical devices. 

Until recently, Russian law classified pharmaceutical packaging products as medical devices. Currently, the register of registered medical devices lists 45 such products, primarily lids and glass or plastic jars.

The situation changed with the entry into force of Recommendation No. 25 of the Board of the Eurasian Economic Commission dated 12.11.2018 (as amended on 29.06.2021) "On the Criteria for Classifying Products as Medical Devices within the Eurasian Economic Union."

According to Recommendation No. 25, the following are not considered medical devices:

• primary, intermediate, and secondary (consumer) packaging of medicinal products, including primary packaging of a medicinal product that is the means of administration (e.g., a multi-dose syringe pen with a built-in non-removable cartridge, a pre-filled syringe);
• a dosing device (dispenser) and (or) a device for dissolving (diluting) a medicinal product (for example, an adapter, a dosing syringe, a dosing cap, a dosing spoon) included in the secondary (consumer) packaging of the medicinal product;
• sachets or tablets with a desiccant placed in the primary or secondary (consumer) packaging of a medicinal product. 

In addition to packaging materials, there is no need to register packaging and equipment for storing medical devices and other products (medicines, etc.) that do not require special storage conditions as a medical device, such as: First aid kit bags (first aid kits, bags and cases for emergency medical care, cases for storing and transporting narcotics, medicines and products that do not require special storage conditions, etc.), eyeglass cases, lens cases; cases for devices (injectors) for administering medications produced in replaceable cartridges.