FDA Labeling Requirements Vs Health Canada Requirements

T

tdeardorff

#1
Hello! I am hoping to get some clear definition to a problem recently encountered. Our company distributes many medical device products which are produced by our suppliers but with our company identification. We sell to Canada and domestically. I recently received communication from a customer recently inspected by HC and they stated the inspector indicated "distributed by" was not acceptable on the product labeling to identify us as the manufacturer. Yet, for the FDA, we are must state distributed by.(or mfg for) How can this be addressed so we only need to maintain one set of labels/products? We have had Distributed By on product labeling for years without any incident with Health Canada. When I contacted HC, the representative indicated that we could put Manufacturer/Distributed By on the labeling but isnt that a contradiction to what the FDA wants? Input/Comments/Similar experience information is appreciated!
 
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#3
The manufacturer must be identified and it does not contradict the requirements of the FDA

Are you the manufacturer or the distributor?
 
Y

yana prus

#4
Hi,

If you sell the products under your name in Canada, you are an OBL manufacturer AND Legal manufacturer according to CMDR, therefore you should follow the HC guidance for private labeling http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/label_marque_pri-eng.php. In addition, you need to obtain the OBL license from Health Canada. Health Canada has an excellent Q&A on Private Label Medical Devices - http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/qalabel_qrmarque_priv-eng.php. With regards to the OEM address it mentions the following:
Q8. Can a private label manufacturer include the original manufacturer's name and contact information on the labelling of a private label medical device?

A. The labelling must include the information set out in subsection 21(1) of the Medical Devices Regulations. The name and address of the private label manufacturer must be provided as per paragraph 21(1)(b). The original manufacturer's name and contact information could also be included as long as they were presented in a manner that would not contravene the clarity requirements of subsection 21(2).

As for the FDA requirements, you can state, manufactured by (that company will be clearance holder), and to mention distributed by with your company identification. As far as I know it is now acceptable in Canada. Maybe other covers could provide you with some more insights on this.

Regards,

Yana
 
T

tdeardorff

#5
Thank you for the helpful information. We are not the manufacturer. We provide products with our company name for products manufactured elsewhere. Most are Class 1 medical devices in Canada. For many years we have supplied devices marked as "distributed by" without problems. At some point in our history we had an FDA inspector identify our product labeling needed to include that wording to meet FDA requirements since we were not the physical manufacturer. Recently a Health Canada inspector identified at a customer location that Distibuted by is not enough to indicate us as the manufacturer according to Canadian regulations. We certainly do not want to disclose the actual manufacturer name. We are considering removing the distributed by in front of our name but also want to make certain this will not present a problem at the next FDA inspection.
 
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