I am out of the office right now. But from memory the FDA country of origin
requirments are covered right at the front of the regs. Something like section
1020, if you are familiar with the laser section which starts around 1040. Then
at the beginning it refrences you back to the section which covers labeling
requirments for all equipment that falls under the scope of the FDA .
-----Original Message-----
From: Brent DeWitt [mailto:bdew...@ix.netcom.com]
Sent: Fri 19/07/2002 02:24
To: Garry Hojan; brent.dew...@us.datex-ohmeda.com;
emc-p...@majordomo.ieee.org
Cc:
Subject: RE: "made in xxxx" requirements?
Gary,
Sorry. It's Medical Electrical Equipment. Both the MDD and FDA have
been
searched with no apparent need for this marking, but this may not be
correct.
-----Original Message-----
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Garry Hojan
Sent: Thursday, July 18, 2002 6:47 PM
To: brent.dew...@us.datex-ohmeda.com; emc-p...@majordomo.ieee.org
Subject: RE: "made in xxxx" requirements?
Hello Brent,
Can you let us know the basic category of product? The marking
requirements
for "Country of Origin" vary depending on the product and of course, the
country that the product is intended to be marketed in. There will be
two
areas that you might have to address this issue, first in the labeling
requirements for an approval, and secondly in the pro forma invoice for
customs and excise.
Best regards,
Garry Hojan
CEO/ President
Strategic Compliance Services (SCS)
a Division of NRL, L.L.C.
11402 E Mariposa Rd.
Stockton, CA 95215
Tel: 209-465-0619
Fax: 209-812-1931
Mobile: 209-662-4322
Email: gho...@regulatory-compliance.com
Web: www.regulatory-compliance.com
-----Original Message-----
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org] On Behalf Of
brent.dew...@us.datex-ohmeda.com
Sent: Thursday, July 18, 2002 4:22 PM
To: emc-p...@majordomo.ieee.org
Subject: "made in xxxx" requirements?
This is not my usual area of interest, but a question came up about
regulations for country of origin marking, either in the US or EU. Can
anyone point me in the direction of an answer?
Thanks all,
Brent DeWitt
Datex-Ohmeda
Louisville, CO
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