The Health Surveillance Agency(ANVISA), the National of Brazil's National Health Supervision Agency, regulates food, drugs, medical devices and other products related to people's health. If you do not pass the ANVISA audit, you can not rush to export these products or even samples to Brazil.

From March 7 to 10, ANVISA appointed a group of experts to conduct a four-day GMP audit of our company. After receiving the official notification letter from Brazil, the State Food and Drug Administration appointed Fu Jinde, a senior expert from the Certification and Approval Center of Jiangsu Food and Drug Administration, as an observer to accompany the inspection throughout the process. Director Jiang Shaobai of the Medical Device Division of Nanjing Food and Drug Administration accompanied Deputy Director Jiang Yongzhao to understand the inspection.

The observer appointed by the National Pharmacy Agency took a photo with the Brazilian expert group.

From checking records, on-site inspections to interview questions, the expert group strictly reviews design and development, process verification, document control, and after-sales service for research and development, procurement, production, and sales. In the end, Brazilian experts believe that the operation of our company's quality system is safe and effective, fully in line with GMP requirements, and there is no non-conformity, through the audit.

Brazilian expert group to view records, interview questions

Brazilian team of experts inspects warehouse site

Site of the last meeting

According to ISO13485 international standards, the company has established a complete quality management system and obtained the EU CE certification as early as 2002. The company will take this audit as an opportunity to continuously improve the level of quality management, improve product quality, enhance the international reputation of the Shuangwei brand, and provide a strong guarantee for expanding the Brazilian and South American markets.

Brazilian expert group photo with company leaders