Hi Brent, The following link lists the relationship between U.S. Customs and the FDA and the only FDA/U.S. Customs rule regarding labeling of country of origin.
http://www.fda.gov/cdrh/manual/ireas.pdf Hope it helps. 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 DeWitt Sent: Thursday, July 18, 2002 6:24 PM To: Garry Hojan; brent.dew...@us.datex-ohmeda.com; emc-p...@majordomo.ieee.org 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 ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list" ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list" ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list" ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
