In the Russian medical technology market, companies often face the need to classify their products. The question of whether a product is considered medical is of strategic importance, as the answer directly impacts the product’s market launch model. Exempting a product from mandatory registration as a medical device significantly reduces timeframes, costs, and increases project profitability. Incorrect classification, however, can lead to administrative penalties, product seizure, and serious damage to the manufacturer’s reputation.
If a product is officially classified as a medical device, its legal circulation will require:
* Completion of the mandatory state registration procedure with Roszdravnadzor.
* Organization of production in accordance with special standards, primarily ISO 13485.
* Compliance with established standards in the field of labeling and packaging.
According to the provisions of Federal Law No. 323 – FZ , under medical product understood any tool , apparatus , instrument , material or other product that is used For medical goals . Main attention at assessment follows devote two aspects :
1. Product Intended Use. A product may be classified as a medical device if its stated functions are related to:
* Prevention, diagnosis or treatment of diseases.
* Monitoring of human health.
* Conducting medical research and analysis.
* Restoration, replacement or correction of anatomical structures or physiological processes.
* Contraception or termination of pregnancy.
2. Principle of action. The key difference between a medical device and a drug lies in its mechanism of action. The action of a medical device is based primarily on physical, mechanical, thermal, or optical properties, rather than on pharmacological, immunological, or metabolic effects on the body. Thus, a correct analysis of the stated purpose and operating principle of a product allows us to draw a well-founded conclusion about its legal status, which forms the foundation for developing a further registration and market launch strategy.
