Boditech Med Receives Approval for Seven AFIAS Diagnostic Kits from Russia’s Health Authority

• Certification completed for seven AFIAS kits: four for cardiovascular diseases and three for inflammatory markers

• Russia’s POCT market rapidly expanding amid growing demand for healthcare modernization and rapid diagnostics

• Certification secured through partnership with local distributor “Avivir”; additional approvals underway

Boditech Med, a company specializing in point-of-care diagnostics, announced on February 14 that it has obtained certification from the Federal Service for Surveillance in Healthcare (Roszdravnadzor, RZN) for seven AFIAS diagnostic kits.

Following the approval of its flagship diagnostic devices AFIAS-1 and AFIAS-6 in 2021, the company has now received certification for four cardiovascular diagnostic kits and three inflammation markers, including CRP, PCT, and IL-6 — all widely used in clinical diagnostics.

Russia, with a population of over 140 million, ranks among the ten most populous countries in the world. However, due to declining birth rates and ongoing geopolitical challenges, the country is undergoing rapid demographic changes, including population decline and aging. These trends have driven an urgent demand for modernized healthcare infrastructure and rapid, accurate diagnostics. Since the COVID-19 pandemic, the importance of point-of-care testing (POCT) has been further highlighted, accelerating market expansion.

According to Grand View Research, Russia’s in vitro diagnostics (IVD) market was valued at $1.97 billion (approx. 2.9 trillion KRW) in 2022 and is expected to grow at an annual rate of over 6%. The POCT segment alone accounts for about 15% of the total market, estimated at $300 million (approx. 430 billion KRW) per year.

The Russian government is actively supporting the development of the IVD and medical device industries through its “2030 National Healthcare Strategy.” As hospitals and medical institutions undergo digital transformation and regional facilities expand remote care systems, the adoption of POCT solutions is accelerating — further fueling growth in this sector.

Eui-yeol Choi, CEO of Boditech Med, stated,

“The Russian market represents a high-potential opportunity in the POCT field. Since 2015, we have made various strategic efforts to enter this market, and with the support of ‘Avivir,’ a local distributor with expertise in IVD, we successfully completed the product registration process and obtained certification.”

He added,

“This approval paves the way for us to actively pursue certification for additional kits in respiratory diseases, hormones, cancer, and more.”