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Hangzhou Zhengda Medical's Touch Screen Automatic Tourniquet System Successfully Obtained Brazilian Medical Device Registration Certificate
origin：Hangzhou Zhengda Medical Co., Ltd. Time：2025-8-15 Hits：1405
Hangzhou Zhengda Medical's Touch Screen Automatic Tourniquet System Successfully Obtained Brazilian Medical Device Registration Certificate
The Brazilian partner of Hangzhou Zhengda Medical Equipment Co., Ltd. (hereinafter referred to as "Hangzhou Zhengda Medical") recently obtained its Brazilian medical device registration certificate, marking that the company's touchscreen hemostasis device has successfully passed the rigorous review of the Brazilian National Health Regulatory Agency (ANVISA).
About the Brazilian Health Regulatory Agency (ANVISA)
The Agência Nacional de Vigilância Sanitária (ANVISA) is an autonomous agency under the Ministry of Health. As part of the Brazilian National Health System (SUS), it coordinates the Brazilian Health Regulatory System (SNVS) and
has nationwide responsibilities.
Official Website: https://www.gov.br/anvisa/en
Safety and Compliance Behind the Rigorous Process
The Brazilian medical device registration review process is extremely rigorous and involves multiple steps, including clinical data evaluation, product performance testing, and quality management system audits at the manufacturing plant. All products applying for registration must meet the high safety and efficacy standards of the Brazilian market and must provide detailed technical documentation and relevant supporting materials. These requirements not only test the product's technical prowess but also demand a high level of expertise in quality control and compliance.
The long process and high costs of continuous investment are a test
Furthermore, the Brazilian registration application process often requires a lengthy review process, often exceeding a year, requiring patience and sustained investment. The relatively high registration fees also make the process even
more challenging. Only companies with a solid foundation in technology R&D, quality management, and compliance operations can successfully navigate these various hurdles.
Hangzhou Zhengda Medical is committed to building a new chapter of cooperation with global medical peers.
Hangzhou Zhengda Medical sincerely looks forward to working hand in hand with its medical device peers to establish long-term and stable partnerships in areas such as technology R&D, market expansion, and regulatory
compliance. Together, we will explore the infinite possibilities of the global medical market, contribute to improving global healthcare services, achieve mutual benefit, and create a new future for the industry.
