Recently, the HCG Pregnancy Test Kit (urine/serum/plasma) from Encode has successfully obtained the registration certificate (81492110028) from the Brazilian National Health Surveillance Agency (ANVISA), granting it approval to enter the Brazilian market. The validity period of this approved registration certificate is permanent. This breakthrough indicates that Encode's ability to access markets and the quality of its products have won the recognition of an international authoritative organization. It represents yet another crucial milestone in its global strategic plan.
The approved HCG Pregnancy Test Card utilizes colloidal gold immunochromatography technology, enabling rapid and accurate detection of human chorionic gonadotropin (HCG) in human samples within a short time frame, with high sensitivity and accuracy. The product supports multiple sample types, including urine, serum, and plasma, and features a simple operation process that requires no specialized equipment. It has the capacity to satisfy the clinical demands of medical institutions in the areas of pregnancy diagnosis, the monitoring of assisted reproduction, and the screening of gynecological diseases. Its stability and inter-batch consistency strictly adhere to international quality standards, providing Brazilian users with a reliable health management tool.
As a leading domestic in vitro diagnostic (IVD) enterprise, Encode has always been dedicated to the research, development, and industrialization of rapid detection technologies. The successful acquisition of the Brazilian ANVISA certification this time represents an important breakthrough for the company in the emerging Latin American market, following its previous attainment of the EU CE international certification. Brazil, as one of the largest medical markets in South America, has a stringent product access system that serves as a benchmark for global IVD enterprises. Relying on its strong technical capabilities and localized service capabilities, Encode will use this certification as a pivot to radiate across the entire Latin America and deepen the cooperation with local medical institutions and distributors.
ANVISA, the central regulatory authority for medical products in Brazil, is renowned for its rigorous and authoritative certification process. The registration certificate recently obtained by Encode not only exempts the company from periodic renewal procedures but also highlights the full lifecycle compliance of its products, establishing a solid foundation for long-term market expansion. Susie Sun, Manager of the International Business Department at Encode, stated, "Securing access to the Brazilian market is a pivotal step in Encode's global strategy. We will continue to refine our product portfolio and advance localized services to contribute to the enhancement of maternal and child health in the region."
In the future, Encode will continue to leverage its technological innovation and quality advantages to accelerate the exploration of emerging markets in Southeast Asia, the Middle East, and Africa. Meanwhile, the company will deepen collaboration with global partners and safeguard human health with precise diagnostic technologies. The approval of the HCG test kit also provides valuable experience and confidence for the entry of Encode's other IVD products into the Latin American market.
