Representative Services

CH - REP

Your Trusted CH-REP for Medical Device Compliance in Switzerland

Under the Swiss Medical Device Ordinance (MedDO), non-Swiss manufacturers must appoint a Swiss Authorized Representative (CH-REP) to place their medical devices on the Swiss market. As your trusted CH-REP, we provide expert regulatory services, ensuring full compliance with Swiss regulations.

Our CH-REP Services

Swiss Authorized Representative (CH-REP) Representation

  • As per MedDO, non-Swiss manufacturers must appoint a CH-REP for legal market entry. We act as your official representative, ensuring full compliance with Swissmedic regulations.

Medical Device Registration & Swissmedic Compliance

  • We assist in medical device registration and compliance with Swissmedic, handling documentation and regulatory filings.

Swiss Market Access & Labeling Requirements

  • We guide manufacturers in meeting Swiss market requirements, including labeling, UDI compliance, and language specifications.

Post-Market Surveillance & Vigilance

  • We support adverse event reporting, compliance monitoring, and regulatory updates to maintain market approval.

Ongoing Regulatory Support & Updates

  • We keep you informed about Swiss regulatory changes and ensure continued compliance with evolving MedDO requirements.

Who Needs a CH-REP?

Contract Manufacturers & Suppliers

Non-Swiss Medical Device Manufacturers without a local presence.

Medical Device & IVD Manufacturers

Companies Exporting Medical Devices to Switzerland.

Distributors & Importers

Regulatory Consultants • seeking Swiss representation for clients.

How to Appoint Us as Your CH-REP?

  • Contact Us – Discuss your Swiss regulatory needs with our experts.
  • Agreement & Documentation – Sign an official CH-REP service agreement.
  • Device Registration & Compliance – We handle Swissmedic registration and regulatory processes.
  • Ongoing Compliance Management – We provide continuous regulatory support and vigilance services.
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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