Regulatory Open Forum

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  • 1.  Country of Origin

    Posted 15-Jan-2013 12:04


    "Country of Origin": Does anyone have a definitive take on the issue where a country will not accept the CE Mark if a regulatory approval is not obtained from the country of origin?  E.g., a US company gets a CE mark, but not yet an FDA approval, yet wants to market in another country outside the US and EU?   Also, what countrys use this principle, preventing sale of US devices if a US (FDA) approval has not been obtained?
     
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    Barry Craner RAC
    Vice President, QA/RA
    Stellartech Research Corporation
    Sunnyvale, CA
    United States
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  • 2.  RE:Country of Origin

    Posted 16-Jan-2013 09:12
    My experience has been that most countries will actually accept CE mark instead of FDA approval/clearance. There are a handful of countries that actually require COO instead of CE. These countries would include China, Thailand, Mexico (more for tender purposes than registration - tenders want COO), Brazil (unless you have GMP certificate issued by ANVISA).

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    Rachael Williamson
    Regulatory Affairs Manager
    Alere San Diego
    San Diego CA
    United States
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    Original Message


  • 3.  RE:Country of Origin

    Posted 17-Jan-2013 10:47
    If your device is manufactured in the USA and is a 510(k) device (i.e. Class 1 or 2), you can often request a Certificate of Exportability from FDA if the device is not yet cleared.  Some countries will accept this along with approval from another GHTF founding member (EU, Australia, Canada, Japan, USA) in lieu of a Certificate to Foreign Government (i.e. evidence that device is cleared in USA).  I am pretty sure Thailand and Brazil accept this approach,  but check with your local Authorized Rep in the country for which you are seeking approval to be sure.

    Please note that for higher risk/PMA-level devices it is not possible to get a Certificate of Exportability without an FDA inspection (at least that has been my experience).

    As a side note - if you have approval in Canada but not the US (COO), you can still apply for approval in Mexico through their "Fast Track" route (they call it "Fast Track", but it is anything but since approval these days seems to be taking 6 - 8 months).  I am not as familiar with the tender process in Mexico; so as Rachel pointed out below it may be moot to apply in Mexico without COO approval unless you plan to go the private payer route.

    Hope that helps!
    KAM

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    Kerri-Anne Mallet
    President & Principal Consultant
    K-Med Regulatory Services, LLC
    West Kingston RI
    United States
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    Original Message


  • 4.  RE:Country of Origin

    Posted 16-Jan-2013 10:22
    Hi Barry,
    I've dealt with CoO issues for a few years now.  The issue you're facing is not uncommon.  Many countries prefer evidence of registration in the CoO, and some, such as China and Taiwan, actually require it.  For the countries that simply prefer it, you can usually provide sufficient evidence of acceptability from another major market, such as Europe.

    For the situation you've described - US company with CE-marked device, awaiting US FDA approval - you can request a Free Sales Certificate (FSC) from the Competent Authority of the EU nation where your EU office or Authorized Representative is located.  This gives you evidence of marketability in the country where the device is registered.  It does not replace the CoO evidence for a market that requires CoO registration, but can get you into most other markets that request evidence of entry into a major market.

    I do not have a complete list of countries that require the CoO registration.  I can tell you that AdvaMed has a working group that has been communicating concerns regarding this CoO requirement to the China SFDA.  They've been working to get this requirement reversed for many years now.

    Best of luck-
    Carole

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    Carole Harris RAC
    International Regulatory Program Manager
    Asuragen, Inc
    Austin TX
    United States
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    Original Message