Fateme,
For the U.S., Canadian, and European medical device jurisdictions, I know of no statute or regulation directly pertaining to distributors lists accompanying a medical device product. However, remember that any documentation accompanying a medical device is generally categorized (and thus regulated) as labeling. Accordingly, a distributors list accompanying a medical device should be prepared and approved via the same labeling controls as any other labeling aspect.
Since such a document is considered to be labeling, and since there are no statutes or regulations directly addressing distributors lists accompanying devices (that I know of within the aforesaid jurisdictions), it means you have wide liberty regarding the format and content.
------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------
Original Message:
Sent: 08-Dec-2021 14:48
From: FATEME FARMAD
Subject: Distributors list in a document accompanying medical device products
Dear community,
We want to include our distributors list in a document accompanying our medical device products. What should be the format of the document? and What information should we put in the documents?
Any feedback is greatly appreciated.
Thank you.
------------------------------
FATEME FARMAD
Quality and Regulatory Affairs Associate
Minnetonka MN
United States
------------------------------