The following summary is provided with regard to export of a medical device without FDA clearance to market by 510(k), Pre Market Approval by PMA or export approval.
A device can be exported without FDA device marketing approval in the United States, if it complies with the following requirements:
- Meets the foreign purchasers specifications (conforms to public specifications provided for marketing in the foreign country),
- Is not in conflict with the laws of the country the device is exported to,
- Is labeled on the outer shipping container "For Export Only",
- Not sold or offered for domestic distribution.
In compliance with the Food, Drug and Cosmetic Act Section 802, the FDA does not approve the export of the device and the device can be exported to any country if:
- the device is manufactured in compliance with Good Manufacturing Practices and
- the device conforms with applicable performance standards such as IEC 601-1/EN60601-1 safety standards, biocompatibility standards, etc. and
- the device has approval to market in one of the following countries:
- Australia
- Canada
- Israel
- Japan
- New Zealand
- South Africa
- Switzerland
- European Union Member Country (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden)
- European Economic Area Country (Iceland, Liechtenstein, Norway)
Prior to export, a notification of export is provided to the FDA.
For support with FDA and International regulations, contact:
Gary Syring, PE, RAC
Quality and Regulatory Associates, LLC
800 Levanger Lane
Madison, WI 53589
E-mail: QRASupport@AOL.com
Phone: 608 877-2635
Fax: 608 873-7382
http://www.qrasupport.com
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Updated: April 26, 2001