Manufacturer Name on Private Brand Labeling

Java23

Involved In Discussions
#11
Hi Ronen,

Thank you for your comments/input. The question stemmed from the fact that our overseas corp. office thinks that IEC 60601 mandates that our company name must be on the rating label, packaging, Instruction Manual...........I had never heard of this previously. My thought is that an OTC that is privately branded need only show the name of the distributor on all levels of packaging.

Corp. Office is stating that IEC 60601 states that 7.2.2 Identification
… shall be marked with the name or trademark of the Manufacturer, and that
7.9 Accompanying documents
7.9.1 General
… shall identify the ME equipment by including, as applicable, the following:
- name or trade name of the Manufacturer and an address to which the responsible organization can refer;


I believe this is being misinterpreted because it is being read that the "legal manufacturer" name and not the distributor name, phone and address be on the label.

Believe me, I am finding this confusing also...........Just seems to me that the private brand distributor name and contact info would fulfill the regulatory requirement.

I guess my question is "can the manufacturer" as is stated in IEC 60601 be interpreted to mean "distributor" which would be more in-line with FDA requirements?

Sorry for the confusion. Thank you! I am ready to bang my head up against a wall :)
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
Hi Ronen,

Thank you for your comments/input. The question stemmed from the fact that our overseas corp. office thinks that IEC 60601 mandates that our company name must be on the rating label, packaging, Instruction Manual...........I had never heard of this previously. My thought is that an OTC that is privately branded need only show the name of the distributor on all levels of packaging.

Corp. Office is stating that IEC 60601 states that 7.2.2 Identification
… shall be marked with the name or trademark of the Manufacturer, and that
7.9 Accompanying documents
7.9.1 General
… shall identify the ME equipment by including, as applicable, the following:
- name or trade name of the Manufacturer and an address to which the responsible organization can refer;
The latest version of IEC 60601 I have defines MANUFACTURER as

natural or legal person with responsibility for the design, manufacture, packaging, or labelling of ME EQUIPMENT, assembling an ME SYSTEM, or adapting ME EQUIPMENT or an ME SYSTEM, regardless of whether these operations are performed by that person or on that person's behalf by a third party
(I added the emphasis)

I guess my question is "can the manufacturer" as is stated in IEC 60601 be interpreted to mean "distributor" which would be more in-line with FDA requirements?
In my opinion yes. Your org has designed, manufactured, packaged and labelled the device, but you client is responsible for all those actions because they're the ones ordering the device from you and placing it on the market under their name.
 

Java23

Involved In Discussions
#13
:thanx: Ronen,

I appreciate your explanation - I think we are close to settling this controversy with our home office - with everyone's input and going back to the CFR and IEC, we were able to support our belief that only the Distributor's name need be on labeling.:applause:

Thank you again and all for your input/explanations - I love this site and have learned much from many!
 
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