What in the composition of a drug can be considered a medical device in national regulation system?

With the development of technologies and the integration of “physics” and “chemistry” a variety of products , which are no longer drugs in the form of classic dosage forms (tablets, ointments, etc.), but the whole systems of delivery of a medicinal substance come into the pharmaceutical market. Such systems involve the use of auxiliary elements that may prove to be medical devices and complicate the process of registration of a drug, as they will require the use of either the already registered MD on the territory of the Russian Federation or the preliminary registration of MD.

We have already written about different categories of borderline products that can be mistaken for a drug. Read more about it in the article: “WHAT ARE DRUGS AND HOW DO THEY DIFFER FROM OTHER PRODUCTS?“[https://beawire.com/drugs/what-are-drugs-and-how-do-they-differ-from-other-products/ ]. However, how to deal with medical devices that may be part of a drug? Like with a syringe for insulin administration? Or with a set of needles in one package with a drug?

Currently, there are a number of insulin drugs on the market, which are multidose disposable syringe pen for multiple injections (NovoMix® 30 Penfill® Novo Nordisk A/C; ROSINSULIN M mix 30/70 of LLC “Zavod Medsintez”). In this case, according to the recommendations N 25 “On criteria for attribution of products to medical devices within the EAEU”, the syringe is a means of administration and does not apply to medical devices.

In general, according to the Recommendations, medical devices do not include:


  1. c) cases for devices (injectors) for the administration of medicines produced in replaceable cartridges. NB: However, the devices (injectors) for administering drugs produced in interchangeable cartridges are

“Primary (internal), intermediate and secondary (consumer) packaging of medicines, including primary packaging of a drug, which is a means of administration (multidose syringe handle with mounted non-removable cartridge).”

For a set of needles designed, for example, for sharing with a syringe, in this case, they will need to be pre-registered as a medical device.

Thus, only a limited range of medical products can be part of the drug kits. In particular, it is MD which is a mean of administration of a medicinal product. In other cases, it is necessary to develop an individual strategy to register combinations of drugs and medical devices.

If you are interested in registering a set of medicines and medical devices, you can get more information by contacting us: info@beawire.com

P.S.: Read about medical devices that include medicines: https://beawire.com/ru/2018/02/09/about-pharmaceutical-agents-in-the-composition-of-medical-devices-and-registration-difficulties/https://beawire.com/2018/02/09/about-pharmaceutical-agents-in-the-composition-of-medical-devices-and-registration-difficulties/


  1. Recommendation of the Board of the Eurasian Economic Commission of 12.11.2018 N 25 “On criteria for attribution of products to medical devices within the framework of the Eurasian Economic Union”
  2. https://grls.rosminzdrav.ru/
  3. https://www.ema.europa.eu/en/documents/product-information/abilify-maintena-epar-product-information_en.pdf