CH-REP: What Is It and Who Needs It?

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 CH-REP (Swiss Authorized Representative)

CH-REP: What Is It and Who Needs It?

What Is a CH-REP?

A CH-REP (Swiss Authorized Representative) is a natural or legal person based in Switzerland who acts as a representative for companies wishing to distribute medical devices on the Swiss market. The abbreviation "CH-REP" stands for "Swiss Responsible Person" and refers to a key role in ensuring compliance with regulatory requirements under the Swiss Medical Devices Ordinance (MedDO).

Why Is a CH-REP Required?

According to the Medical Devices Ordinance (MedDO, SR 812.213), manufacturers without a registered place of business in Switzerland must appoint a CH-REP. This representative assumes essential responsibilities to ensure the conformity of products with Swiss regulations:

  • Legal Responsibility: The CH-REP serves as the official representative of the manufacturer and assumes regulatory responsibility towards Swiss authorities.
  • Regulatory Compliance: Ensures that all requirements of the Medical Devices Act are met.
  • Point of Contact for Authorities: Acts as the main contact for Swissmedic and assists with handling safety and quality inquiries.
  • Support in Market Surveillance: Assists manufacturers in reporting incidents and ensures proper documentation and traceability of products.

Who Needs a CH-REP?

  • Manufacturers Outside Switzerland: Companies based abroad that wish to sell medical devices in Switzerland are required to appoint a CH-REP.
  • Importers and Distributors: If the importer or distributor is not based in Switzerland, the CH-REP can act as the responsible person.

Conclusion

A CH-REP is essential for all non-Swiss manufacturers of medical devices to ensure market access in Switzerland. The CH-REP ensures compliance with legal requirements and serves as a liaison between manufacturers, authorities, and market participants.

Sources


❓Are you a non-Swiss manufacturer or distributor of medical devices or in-vitro diagnostics looking to enter the Swiss market? Contact us today!

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