The 5-Second Trick For seniorenpflege schweiz
The 5-Second Trick For seniorenpflege schweiz
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Final studies organized in accordance with Write-up eighty four paragraph 5 EU-IVDR needs to be submitted to Swissmedic. The transfer of such obligations through the company into the authorised consultant should be agreed in producing from the mandate.
The manufacturer should normally, with no exception, be indicated on the gadget alone or to the packaging.
Distributors are not obliged to indicate their address over the product or inside a doc accompanying the machine if they are only giving gadgets.
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There exists also a constrained registration prerequisite for in vitro diagnostic medical equipment (IvDV Post 10).
The notification could be performed with the company or its Swiss-approved consultant, which need to be clearly controlled inside the agreement between The 2 economic operators. However, the authorized agent is liable for the reporting obligation.
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Where by an authorised consultant is needed pursuant to Short article 51, this representative is responsible for the reporting obligation in paragraph 1. Moreover, the authorised representative need to post the craze stories pursuant to paragraph 2 on incidents in Switzerland and abroad to Swissmedic with no remaining asked for to do so.
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Beneath the revised Swiss Medical Professions Act, as of one January 2018 anybody training a medical occupation demanding a College qualification who will work in Switzerland needs to be recorded within the sign up of medical professions.
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Distributors are usually not obliged to offer their handle around the system. Distributors could also act as licensed Reps but usually are not instantly the approved agent.