CH-REP

Market access to Switzerland

Medical devices and the regulatory framework

CE marking 

(in compliance to MDR/MedDO or IVDR/IvDO)

We guide you on your journey

  • From product idea,
  • through development, 
  • setup of quality system,
  • to complete technical documentation.

To your CE mark and beyond.

Swiss Authorized Representative (CH-REP)

We represent you as your CH-REP

  • From compliance review
  • through registration,
  • market oversight and regulatory intelligence,
  • to incident handling.

Full support for all things Switzerland.

Why choose us?

Your contact in Switzerland

  • >20 year track record in Switzerland. We stand with our own name. 
  • Well connected network in Switzerland
  • Regulatory intelligence for Switzerland (other markets available, such as EU, US, Australia)
  • Strong expert quality, regulatory and clinical background
  • Standardised CH-REP processes
  • Contained, transparent costs
  • Product liability insurance available
  • Pure CH-REP function: no competition clause
  • Fully registered with Swissmedic as CH-REP

Work with us

CH-REP onboarding process

How we support you

Medical devices for the Swiss market

  • Regular updates on regulatory landscape in Switzerland
  • Support tailored to your products 
  • Compliance review and gap analysis (ISO13485, MDSAP, MDR, IVDR, MedDO, IvDO, ISO9001 ao)
  • Economic operator trainings (Manufacturers, Importers, Distributors, CH-REPs, PRRCs)
  • Incident handling
  • Communication with Swissmedic, Notified body, economic operators.
  • On demand regulatory advise as an established partner 
  • Network acceleration within Switzerland

Kontaktieren Sie uns

Kontaktieren Sie uns für mehr Informationen

taoexCH-REP