On March 24, 2026, a professional audit team from Roszdravnadzor (RZN), the Federal Service for Surveillance in Healthcare of the Russian Federation, conducted an official on-site verification audit at Trifanz Medical. This audit is a critical step for medical device registration and market access in Russia and the Eurasian Economic Union.
Our company's management team fully supported the audit process. The audit experts carefully reviewed our quality management system, production procedures, GMP cleanroom conditions, equipment operation, product traceability, sterility control, and official certification documents. After thorough inspection and evaluation, Trifanz Medical passed the entire audit with zero non-conformities.
This achievement reflects our strict quality management philosophy and strong compliance capabilities. It also strengthens our position in global market expansion and lays a solid foundation for officially entering the Russian market.
At present, Trifanz Medical has obtained medical device registrations (including applications under process) in 18 countries and regions, and our products are sold to more than 80 countries worldwide.
In the future, we will continue to optimize production management, enhance product innovation, and maintain high international safety standards for medical consumables. We will accelerate the follow-up registration process in Russia and bring reliable airway management, respiratory care, and anesthesia products to global clinical partners.