Noul has completed registration with Brazil's National Health Surveillance Agency.

Noul Co., Ltd. (CEO Chan-Yang Lim, hereinafter referred to as Noul) announced on the 29th that it has completed registration for use of its AI-based blood analysis solution, "miLab™ BCM," with the Brazilian National Sanitary Surveillance Agency (ANVISA). This registration holds significant strategic significance for Noul, as it formalizes its entry into Brazil, the largest medical device market in Central and South America, and establishes a bridgehead for market expansion across the region.

This registration allows Noul to fully enter the $5.9 billion South American blood analysis market, leveraging its AI-based blood analysis solution, miLab™ BCM. This registration is expected to accelerate sales growth in Brazil and Latin America through various channels, including expanding export contracts, establishing local partnerships, and participating in public procurement. Noul's AI-based cervical cancer solution, miLab™ CER, and malaria diagnostic solution, miLab™ MAL, are also undergoing review under the Medical Device Single Review Program (MDSAP) for entry into the Latin American market.

Noul CEO Chan-Yang Lim stated, "Brazil is a key market for the South American medical device market, and product registration with ANVISA is more than just market entry. It reaffirms the international trust in Noul's technological prowess in the highly regulated Brazilian market." He added, "We will quickly complete registration of our cervical cancer and malaria product lines to fully expand our business across South America."

Brazil, the world's sixth most populous country and a massive market accounting for approximately 45% of South American medical device demand, requires product registration with ANVISA, the regulatory authority, to sell in vitro diagnostic products. ANVISA registration is known to require complex and stringent requirements, including GMP audits and the designation of a local corporation or import agent. It is also used as a reference certification for product registration in other South American countries, such as Argentina, Chile, and Peru.

Meanwhile, Noul recently completed registration for use in the Swiss market of AI-based software and three cartridges (miLab™ Cartridge CER, miLab™ Cartridge BCM, miLab™ Cartridge MAL) for cervical cytology, blood analysis, and malaria testing, and is continuing its efforts to expand global sales by signing a contract in March to supply three miLab products, including a cervical cancer diagnosis solution, to six Central American countries, including Panama.

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