AEMPS (Spain) Registration - Medical Devices - We do not own the products we make

[fialor]

I am hoping to get some help with my question below.

I understand that any legal manufacturer of a medical device based in Spain must first register with AEMPS to get a license to manufacture and place the medical device on the market in Spain. This is clear.

But I am a company who manufactures/final assembly of products for another business based in the EU who CE mark the medical device that my Company makes. The legal manufacturer is EU based but not in Spain. And the legal manufacturer understands they need to register the products with AEMPS before it is placed on the market in Spain.

As a company we do not own the products we make, nor do we CE mark them, do we have to register with AEMPS before we can manufacture the devices for this other Company?

Thanks for your responses.

 

[fialor]

In case anyone is in the same position as I was.

I asked the question directly of AEMPS and their response is below:

My question to AEMPS:
I understand that any legal manufacturer of a medical device based in Spain must first register with AEMPS to get a license to manufacture and place the medical device on the market in Spain.

But I am a company who manufactures/final assembly of products for another business based in the EU who CE mark the medical device that my Company makes.
As a company we do not own the products we make, nor do we CE mark them, do we have to register with AEMPS before we can manufacture the devices for this other Company?

The AEMPS Response:
Dear Madam,
Only Manufacturers that markets the medical devices under its name, and are established in Spain, must obtain an operating license from the Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios).

 

[Marc]

Thanks for letting us know. I'm sorry you didn't get a response from anyone here.