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
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
Ronen,