P
pccaro
Hello All,
After following this site, I hope there is some one that have an answer for me. My questions is in regard to OEM, OLB and Private labeling.
I'm new in the regulatory area and I have a project to identify the best path to take to have foreign equipment labeled with our company name and logo, knowing that the equipment contain a CE mark.
Scenario 1.
My Company (B) buys equipment from company A (foreign company). Company A label their equipment with name and logo of Company B. Is this consider OBL or private label?
Scenario 2.
Company B buys equipment from Company A. Company B places label and logo to the equipment in USA. Company B re-sells these equipment in USA and Europe. I know we can use the same NB number if we work with the same Notify Body of Company A; however, what is the process/regulations for this? Who contacts the NB; Company A or B? what if, Company B decided to use a different NB? Does Company B is consider an OEM or OBL?
Scenario 3:
Company B buys equipment from Company A, but just re-sell them in USA and Europe? What are the requirements/regulations as Distributors?
Additional Questions:
What is the responsibility of an OBL in regards to the Technical File?
Does an OBL still require to have a Quality System in place?
I hope some one can help me with this. I apologize for too many questions, but I'm so confuse with OEM, OBL and private labeling. Thank you in advance for your support.
Regards,
Priscilla
After following this site, I hope there is some one that have an answer for me. My questions is in regard to OEM, OLB and Private labeling.
I'm new in the regulatory area and I have a project to identify the best path to take to have foreign equipment labeled with our company name and logo, knowing that the equipment contain a CE mark.
Scenario 1.
My Company (B) buys equipment from company A (foreign company). Company A label their equipment with name and logo of Company B. Is this consider OBL or private label?
Scenario 2.
Company B buys equipment from Company A. Company B places label and logo to the equipment in USA. Company B re-sells these equipment in USA and Europe. I know we can use the same NB number if we work with the same Notify Body of Company A; however, what is the process/regulations for this? Who contacts the NB; Company A or B? what if, Company B decided to use a different NB? Does Company B is consider an OEM or OBL?
Scenario 3:
Company B buys equipment from Company A, but just re-sell them in USA and Europe? What are the requirements/regulations as Distributors?
Additional Questions:
What is the responsibility of an OBL in regards to the Technical File?
Does an OBL still require to have a Quality System in place?
I hope some one can help me with this. I apologize for too many questions, but I'm so confuse with OEM, OBL and private labeling. Thank you in advance for your support.
Regards,
Priscilla