Major International Certification Breakthrough: Biosis Healing Awarded ANVISA GMP Certificate

Recently, Biosis Healing has successfully obtained the GMP certificate from Brazil’s National Health Surveillance Agency (ANVISA). This certification covers all the company’s Class IV medical devices, confirming that its manufacturing and quality management system meets top international standards. It lays a solid foundation for market access in Brazil and creates favorable conditions for further expansion across Latin America.

As a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), Brazil’s ANVISA GMP certification is widely recognized as a key entry document for Brazil and other PIC/S member countries. During the official audit, two ANVISA inspectors spent one week on-site, conducting a full review of product design and development, procurement, production, quality control, and the entire quality management system.

As a platform enterprise focused on R&D and industrialization of absorbable biological membrane and degradable implantable biomedical materials, Biosis Healing passed the inspection with advanced production and testing equipment, precise process control, and a complete product traceability system covering the full product lifecycle. This achievement fully demonstrates the company’s strong technical capabilities and robust quality management system.

Brazil is the largest economy and most populous country in Latin America, with strong demand for high-quality medical devices. Obtaining the ANVISA GMP certificate marks a critical step for Biosis Healing to officially enter the Brazilian market. The company will accelerate commercial deployment in Brazil and expand into other Latin American markets.

Going forward, Biosis Healing will continue to increase R&D investment in biomedical materials, advance cutting-edge technology research, achievement transformation, and industrialization. The company will enrich its product portfolio and enhance core competitiveness, while pursuing higher-standard international registrations and certifications to help more innovative products gain global recognition. By fulfilling its corporate mission, Biosis Healing supports the high-quality development of China’s high-end medical device industry and accelerates its expansion into the global market.