Mangafanga
Starting to get Involved
Greetings!!
I have an agreement with a Medical device manufacturer to manufacture and sell devices to few specific countries under my license for those countries. However, they are the Legal manufacturer (owns the CE Certificate). Because importing their devices would not make sense financially, I manufacture (assemble) the devices (I am also a Medical device manufacturer and have QMS) and obtain licenses under my name when I sell to the countries. However, I don't own the design neither the technical file, i only maintain the manufacturing documents after design transfer. One of the countries I have having problem because I am retaining the legal manufacturer label where I just mentioned manufactured by "My company".
Question:
1. Can I remove the Legal Manufacturer label? (remember, I just manufacture and obtain licenses for country specific by showing contents of their technical file and show the agreement that I have with them)
2. Can I myself become the Legal manufacturer? The same device would then exist under the name of two legal manufacturers, is that possible?
3. Do I have to re-write all the technical documents or can i just re-label and remove their names from all labeling (do OBL (Own Brand Label))?
4. Is it possible to transfer Legal manufacturer name or co-own legal manufacturer status?
I have an agreement with a Medical device manufacturer to manufacture and sell devices to few specific countries under my license for those countries. However, they are the Legal manufacturer (owns the CE Certificate). Because importing their devices would not make sense financially, I manufacture (assemble) the devices (I am also a Medical device manufacturer and have QMS) and obtain licenses under my name when I sell to the countries. However, I don't own the design neither the technical file, i only maintain the manufacturing documents after design transfer. One of the countries I have having problem because I am retaining the legal manufacturer label where I just mentioned manufactured by "My company".
Question:
1. Can I remove the Legal Manufacturer label? (remember, I just manufacture and obtain licenses for country specific by showing contents of their technical file and show the agreement that I have with them)
2. Can I myself become the Legal manufacturer? The same device would then exist under the name of two legal manufacturers, is that possible?
3. Do I have to re-write all the technical documents or can i just re-label and remove their names from all labeling (do OBL (Own Brand Label))?
4. Is it possible to transfer Legal manufacturer name or co-own legal manufacturer status?
