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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint745,110 companies indexed · Last updated: today
DirectoryBusiness & Technical ServicesAdministrative ServicesAarauMDSS CH GmbH
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MDSS CH GmbH

Summary

About the company

MDSS CH GmbH is an Authorized Representative (CH-REP) for medical devices and in vitro diagnostic devices, serving as the formal contact for competent authorities and overseeing registration, vigilance reporting and other regulatory compliance tasks.

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Swiss Authorized Representative (CH-REP)
Authorized representative for medical devices and IVDs, registration with Swissmedic and Swissdamed, review of technical documentation, reporting of incidents, recalls and non-conforming products.
Free Sales Certificate (FSC / CFS)
Application for Free Sales Certificates, Certificate of Free Sale and Certificate of Marketability for export to more than 60 countries, including notarisation and legalisation requirements.
National product registration
National product registrations in EU member states with additional reporting obligations, including EUDAMED and authority registrations, as well as GMDN code research.
EU Authorized Representative (EC REP)
EU authorized representative for medical devices and IVDs, mandate for manufacturers outside Europe, support with MDR and IVDR requirements, and EU registration.
UK Responsible Person (UKRP)
UK authorized representative for medical devices and IVDs, MHRA registration, technical documentation, evidence of conformity and support for manufacturers outside the United Kingdom.
U.S. Agent
U.S. agent for medical devices and IVDs, FDA communication, support for registration, listing, inspections and requests for manufacturers outside the USA.
Australian and New Zealand Sponsor
Sponsor service for Australia and New Zealand, ARTG and WAND registration, contact with the TGA and Medsafe, support with labelling, technical documentation and vigilance.
EU Representative for the General Product Safety Regulation (GPSR)
EU representation for products under the GPSR, mandate for manufacturers outside the EU, contact for market surveillance authorities and support for safety measures.
EU Representative for the General Data Protection Regulation (GDPR)
EU representation under Article 27 of the GDPR for controllers and processors established outside the EU, contact point for authorities and data subjects, and support for the RoPA.
Importer of Products
Import services for medical devices to the European market, review of documentation and registrations, warehousing and transport control, as well as complaint handling and recall management.
Training and Workshops
On-site workshops, seminars and MDSS Forum+ on MDR and IVDR implementation, CE labelling, post-market surveillance, vigilance and technical documentation.
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Location

Laurenzenvorstadt 61
5000 Aarau

At a glance

Legal form
Limited Liability Company
UID
CHE-469.219.639
Founded
2021 · 5 years
Last commercial register change
November 15, 2021
Employees
1 to 10

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