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Sipsongpanna
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.
RELIABLE / UNCOMPLICATED / CHEAP
CH-REP procedure
1
Creating offer
Creating offer according to the information provided by the manufacturer and the individual needs.
2
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
3
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)“.
4
Document transfer
- Declaration of conformity/ies
- Technical documentation/s
- QM and CE certificates
5
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!
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.
7
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
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