Hello All,
Our company could really use some advide on the given scenario for our new busienss expansion, We wish to set up a new HQ for a private label/virtual manufacturing medical device brand , Mainly using OEM manufacturers in China to produce the medical devices and/or Consumables.
The original idea was to set up in Germany, as we plan to market the products in mainly parts of africa and Middle east , some countries may not even need the CE Mark to be able to market there, however a vast majority will still have CE Mark.
Coming up the new MDR Regulations will this affect the possiblity to become a virtual manufacturer from German? can we easily obtain certificate of origin and label the product with the german company details to market the products outside the EU Market?
If this is not possible and will be affected by the regulations , what is a reputable global country where its brands are respected in the developing world, which have a smooth regulatory procedeure to become a virtual manufacturer for medical devices.
Our company could really use some advide on the given scenario for our new busienss expansion, We wish to set up a new HQ for a private label/virtual manufacturing medical device brand , Mainly using OEM manufacturers in China to produce the medical devices and/or Consumables.
The original idea was to set up in Germany, as we plan to market the products in mainly parts of africa and Middle east , some countries may not even need the CE Mark to be able to market there, however a vast majority will still have CE Mark.
Coming up the new MDR Regulations will this affect the possiblity to become a virtual manufacturer from German? can we easily obtain certificate of origin and label the product with the german company details to market the products outside the EU Market?
If this is not possible and will be affected by the regulations , what is a reputable global country where its brands are respected in the developing world, which have a smooth regulatory procedeure to become a virtual manufacturer for medical devices.
