Good news reaches South America, a new compliant journey begins! Recently, Wanhai Medical’s pen injector product series has passed rigorous comprehensive review by Brazil’s National Health Surveillance Agency (ANVISA), obtaining the core access qualification for the Latin American market.
ANVISA represents the strictest medical device certification in South America. This certification proves that our product quality and production system fully meet Brazil’s official standards, enabling nationwide sales in Brazil and market expansion across all of Latin America.
Possess a full suite of international qualifications including ISO13485, CE MDR and MDSAP, and the FDA certification application is currently in progress. Our pen injectors are compatible with various pharmaceuticals such as insulin and GLP1 peptides, serving numerous pharmaceutical enterprises across South America.
This certification marks an important milestone in the company's global layout. Moving forward, Wanhai Medical will continue to deepen its overseas presence, explore global markets with high-standard self-administration devices, and help domestic medical devices thrive in Latin America.
Hey, I'm Mike, a R&D engineer at Wanhai Medical, and I work with injection pens every day.
In the past decade, we have provided products and integrated services to over 180 renowned pharmaceutical companies, serving clients across more than 60 countries and territories worldwide.
My days are a "battle for details". This job's meaning is in countless "gentle moments". It turns cold medical processes into warm help, easing long-term injectors' fear and boosting their confidence. Behind it all is my social responsibility, rooted in professionalism and passion: "to make sure every user is well cared for."
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