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What is a Medical Device?

Under Article 38 of Federal Law No. 323-FZ "On the Fundamentals of Health Protection of Citizens in the Russian Federation," a medical device is any instrument, apparatus, appliance, device, equipment, material, or other item used individually or in combination — including software — that is intended by its manufacturer to be used for medical purposes in relation to humans, including:

  • diagnosis, prevention, monitoring, treatment, or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation, or compensation of injury or disability
  • study, replacement, or modification of the anatomy or of a physiological process
  • control of conception

The key distinguishing feature is the intended purpose as stated by the manufacturer. A product used for a medical purpose, as declared in its labelling or instructions, is a medical device regardless of whether it achieves its principal intended action by pharmacological, immunological, or metabolic means — if such means are only ancillary.

IVD medical devices​

In vitro diagnostic (IVD) devices — reagents, calibrators, control materials, kits, instruments, and software used for examination of specimens derived from the human body — are also regulated as medical devices in Russia and must be registered with Roszdravnadzor before they can be placed on the market.

Software as a Medical Device​

Standalone software can qualify as a medical device in Russia. Roszdravnadzor published methodological guidelines in 2018 establishing criteria for when software constitutes a medical device and how it should be classified. See the Digital Health & SaMD section for details.

What is not a medical device?​

Products that fall outside the medical device definition include:

  • Products achieving their principal intended action by pharmacological, immunological, or metabolic means (these are medicines or biologics)
  • Cosmetic products with no medical purpose
  • General consumer electronics with no declared medical intended purpose
  • Food and dietary supplements

If there is doubt about whether a product is a medical device or falls under another regulatory framework, you can seek a classification opinion from Roszdravnadzor.

Official source

Article 38, Federal Law No. 323-FZ: base.garant.ru/12180860/