CH-REP & Medical Regulatory Services

Luptek GmbH is registered as Swiss authorised representative (CH-REP) under Art. 51 MedDO and as Importer for class I medical devices.

What we do for foreign manufacturers

• Swiss mandate agreement including a technical documentation clause
• Registration in the Swissmedic database (swissdamed)
• Vigilance reports to Swissmedic under Art. 66 MedDO
• Complaint and incident management
• Market surveillance and recall coordination
• Label check (CH-REP address, Swiss languages)

Interested? Write to us via the Contact form and we will come back to you within 1 to 2 working days with a non-binding offer.