Swissmedic, Switzerland’s therapeutic products regulator, oversees medical devices under national and European laws. It certifies that compliant medical devices can enter the Swiss market and its treaty nations unrestrictedly, based on submitted documentation.

CE Certification ensures medical devices conform to EU regulations, guaranteeing safety, health, and environmental protection standards. It’s a legal requirement for devices sold within the European Economic Area.

ISO 13485:2016 defines a quality management system for medical device manufacturers, focusing on safety and efficiency throughout the product lifecycle. It ensures devices consistently meet customer and regulatory standards, applicable globally across all stages from design to post-market1

The British Hypertension Society is a leading authority on hypertension, dedicated to research, education, and clinical practice in the UK, driving advancements in hypertension prevention, diagnosis, and treatment.

The European Society of Hypertension (ESH) is a premier organization dedicated to advancing knowledge, research, and clinical practice in hypertension across Europe.

The Taiwan Food and Drug Administration (FDA) regulates the safety and quality of food, drugs, medical devices, and cosmetics in Taiwan. It oversees the approval, manufacturing, labeling, and distribution of these products to ensure they meet stringent standards and protect public health.