Swissmedic

The Swiss Agency for Therapeutic Products (Swissmedic) is Switzerland's national authority responsible for authorizing and supervising therapeutic products. Swissmedic’s oversight includes medical devices, IVDs, human and veterinary medicines, vaccines, blood and blood products, and narcotics. Swissmedic is attached to the Federal Department of Home Affairs but operates as an autonomous organization.

When was Swissmedic established?

Swissmedic began operations on 1 January 2002. It was created by the Federal Act on Medicinal Products and Medical Devices.

What primary medical device regulations does Swissmedic enforce?

The legislation on therapeutic products comprises the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). Switzerland has adapted its medical devices regulations to EU rules. Compliance obligations for medical devices and IVDs are primarily governed by MedDO (Medical Devices Ordinance), which has been in force since 26 May 2021, and IvDO (In Vitro Diagnostics Ordinance), which has been in force since 26 May 2022.  

How does Swissmedic relate to the EU medical device regulatory system?

Switzerland is not an EU member state. As a result, its medical device regulatory infrastructure is separate from the EU and it maintains its own medical device database, swissdamed. Economic operators must complete mandatory registrations of companies, persons, and products directly with Swissmedic separately from any EU obligations. Despite the separation, medical device sold in Switzerland must bear the CE Mark under applicable EU rules.

How do I contact Swissmedic?

For general questions about Swissmedic or a specific substance, the Communication division can answer straightforward questions by telephone at +41 58 414 07 70. Complex inquiries can be submitted in writing via contact form. Note that written information is provided at a base rate of CHF 200 per hour, though certain groups receive free-of-charge responses.  

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Website: Swissmedic  
Address: Hallerstrasse 7, 3012 Bern, Switzerland  
Phone: +41 58 414 07 70
Email: Contact form

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