We are a small company that produces general lab centrifuges with the option for private label agreements with distributors, this allows distributors to register the devices as class 1 in some cases.
We currently have a Swiss distributor who has registered their private labeled device as class 1 and is insisting that they're being told they need a Certificate of Origin legalized by our Chamber of Commerce for every shipment that we send them. This presents 2 major problems:
1. This process is expensive and we're not willing to eat the cost of legalization by the chamber of commerce for the number of shipments that they receive.
2. This process is SLOW and seems to be getting slower, this holds up shipments and hurts our OTD KPI.
It seems to me like this could be handled similarly to a USMCA agreement (legalize the document once for the product they purchase and then simply have it renewed every year). This would cover all shipments for an entire year but am unsure if this is an actual requirement for every shipment. I've tried to find specifics related to import/export documentation requirements in the Medical Device Ordinance (MedDO) but it very vague, only stating that "appropriate documentation" is required.
Has anyone had any experience dealing with the Swiss MedDO that could give me any guidance here? The distributor is really holding their ground here but cannot provide us with a specific regulation that points to this requirement.
Thank you all in advance!
We currently have a Swiss distributor who has registered their private labeled device as class 1 and is insisting that they're being told they need a Certificate of Origin legalized by our Chamber of Commerce for every shipment that we send them. This presents 2 major problems:
1. This process is expensive and we're not willing to eat the cost of legalization by the chamber of commerce for the number of shipments that they receive.
2. This process is SLOW and seems to be getting slower, this holds up shipments and hurts our OTD KPI.
It seems to me like this could be handled similarly to a USMCA agreement (legalize the document once for the product they purchase and then simply have it renewed every year). This would cover all shipments for an entire year but am unsure if this is an actual requirement for every shipment. I've tried to find specifics related to import/export documentation requirements in the Medical Device Ordinance (MedDO) but it very vague, only stating that "appropriate documentation" is required.
Has anyone had any experience dealing with the Swiss MedDO that could give me any guidance here? The distributor is really holding their ground here but cannot provide us with a specific regulation that points to this requirement.
Thank you all in advance!
