Who/What is Swissmedic?

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Swissmedic


Swissmedic: The Swiss Agency for Therapeutic Products

Swissmedic is the Swiss regulatory and supervisory authority for therapeutic products, including medical devices and pharmaceuticals. It is an independent public institution under federal law and operates under the Federal Department of Home Affairs (EDI). Swissmedic plays a key role in the regulation, approval, market surveillance, and safety of therapeutic products in Switzerland.

Tasks and Responsibilities of Swissmedic

  • Approval and Registration: Swissmedic is responsible for approving pharmaceuticals and medical devices. It evaluates the safety, efficacy, and quality of products before they can be marketed in Switzerland.

  • Market Surveillance: The agency continuously monitors the safety and quality of products through inspections and vigilance reports to identify potential risks at an early stage.

  • Safety Management: Swissmedic assesses safety risks and implements necessary measures, including recalls or safety warnings for defective or high-risk products.

  • Regulatory Guidance: Companies receive guidance from Swissmedic on the approval and compliance of medical devices. The agency informs about legal requirements and assists with documentation.

  • International Cooperation: Swissmedic collaborates with organizations such as the European Medicines Agency (EMA) and the World Health Organization (WHO) to ensure international safety standards.

Legal Framework

Swissmedic operates based on the following legal foundations:

  • Therapeutic Products Act (HMG, SR 812.21): Regulates the approval and supervision of therapeutic products in Switzerland.

  • Medical Devices Ordinance (MedDO, SR 812.213): Contains regulations for placing medical devices on the market and their market surveillance.

Sources

Swissmedic ensures the safety, quality, and efficacy of therapeutic products in Switzerland, making a crucial contribution to public health protection.


❓Are you a non-Swiss manufacturer or distributor of medical devices or in-vitro diagnostics looking to enter the Swiss market? Contact us today!


Location: Zug, Schweiz

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