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CH-REP and other services

You need an authorized representative in Switzerland (CH-REP) and maybe other services!? Then you are just right at Sipsongpanna Holding AG.


CH-REP procedure


Creating offer

Creating offer according to the information provided by the manufacturer and the individual needs.


Onboarding of the manufacturer and its´products

  • Review of the offer with the manufacturer and offer acceptance
  • Discussion of product/s (Declaration of Conformity/ies)
  • Training of market requirements in Switzerland
  • Discuss the processes and adjust it if necessary
  • Exam for completeness and correctness of the technical documentation/s and the QM and CE certificates


Mandating as CH-REP

Mandating as a CH-REP by the manufacturer on the contract „Designation of a Swiss Authorised Representative (CH-Rep) under the Swiss Medical Device Ordinance (MedDO)“.


Document transfer

  • Declaration of conformity/ies
  • Technical documentation/s
  • QM and CE certificates


Message of the Mandate at Swissmedic

  • Information of the message to the manufacturer
  • From this point on, the medical devices can be delivered (exported) from the manufacturer to Switzerland.
  • Pay attention on point 6!


Labeling "CH-REP" to the manufacturer's products

CH-REP checks the correct attachment of the „CH-REP“ label from the manufacturer and officially releases this.


The following year/s

  • Routine communication
  • Update and check, among other things, innovation/change in the certification status, the Declaration of conformity/ies, further changes/innovations, add or deletion of products
  • Recording and reporting of market information (e.g. complaints from clients)
  • Update and check new requirements of Swissmedic
  • Communication with Swissmedic

Further services

  • Regulatory consultancy
  • Support for the market entry in Switzerland
  • Warehousing and Logistics
  • Swiss company foundation and administration
  • Capa’s
  • Market monitoring

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