A "Swiss Authorised Representative" / "CH-REP" is a natural or legal person established in Switzerland who is mandated in writing by a manufacturer established abroad to perform certain tasks on his behalf in fulfillment of obligations of the manufacturer arising from this Ordinance.
The following points must be taken into account when appointing the "Swiss Authorised Representative":
CH-REP.com aims to provide tailor-made, compliant and useful services to both foreign manufacturers and importers and distributors in Switzerland.
The CH-REP is appointed by the foreign manufacturer as the Swiss Authorised Representative. The following steps will provide the path to designation:
The foreign manufacturer contacts the potential CH-REP at ar@ch-rep.com. In order to be able to prepare a quotation, at least the following information is required:
- Product overview, product classification according to (EU) 2017/745
- Number of technical documentations per product class
- Number of GMDN codes
The possible CH-REP prepares an offer based on the information provided by the foreign manufacturer.
The foreign manufacturer checks the offer, clarifies the open points / questions with the possible CH-REP and decides to cooperate with the CH-REP.
The designated CH-REP reviews the documents transferred by the foreign manufacturer, clarifies the open points / questions with the foreign manufacturer and decides whether the designation by the foreign manufacturer is possible.
The designated CH-REP prepares the contract together with the applicable annex documents (Annex I - Medical Devices, which are part of the contract; Annex II - Communication_Contact Data; Annex III - Compensation Agreement for the Provision of Services; Annex IV - Notification of Change to the Swiss Authorized Representative).
The designated CH-REP sends the contract together with the applicable annex documents to the foreign manufacturer for signature.
Once the contract is signed, the mandate is reported to Swissmedic (Swiss authority) by the "Swiss Authorised Representative".
The CH-REP informs the foreign manufacturer about the notification of the mandate. From this point on, the medical devices can be delivered to Switzerland (taking into account the obligations according to the contract and the affixing of the addresses of the CH-REP). Communication_contact details; Annex III - Compensation agreement for service provision; Annex IV - Notification of change to the Swiss authorized representative).
The designated CH-REP sends the contract together with the applicable annex documents to the foreign manufacturer for signature.
The foreign manufacturer informs the CH-REP according to the contract.
The CH-REP fulfills its services according to the contract.
Contact us by email at ar@ch-rep.com
You will receive prompt feedback.