Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020

#1
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.
 
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#2
After May 2021, there's no OEM/PLM system anymore (regarding CE). Well, another three years for combinations already set up, but once one of the two switches to MDR, then other one is screwed.

Under MDR, you are the Manufacturer. You will have to provide the full technical documentation and you have full responsibility for everything. Your former OEM partner is now just a (critical) supplier. So joy for all those who want to have their own name on the device they resell. And it's amazing how many there are.
 
#3
After May 2021, there's no OEM/PLM system anymore (regarding CE). Well, another three years for combinations already set up, but once one of the two switches to MDR, then other one is screwed.

Under MDR, you are the Manufacturer. You will have to provide the full technical documentation and you have full responsibility for everything. Your former OEM partner is now just a (critical) supplier. So joy for all those who want to have their own name on the device they resell. And it's amazing how many there are.

This raises a big question, does the same apply to just wanting to market the products outside the EU, Secondly which reputable region around the globe still provides a comfortable HQ in terms of regulations for OEM/OBL/Virtual manufacturers? Is the same full technical documentation required in other key parts of the world? Canada, USA, Singapore, ETC ETC
 
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