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  • 1.  Documentation for foreign markets

    Posted 15-Jun-2017 10:41

    I'm working on pulling some documentation for a foreign market that may import a product.  On the list that the market provided, for several documents, besides notarization and legalization, they request a "stamp from the MOH" or "certified by MOH".  Does anyone have experience with this?  I don't think that FDA does something like this.  Is there a work around?  (It's for a Middle East Market).

    Marcy



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    Marcy Sussman RAC

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  • 2.  RE: Documentation for foreign markets

    Posted 15-Jun-2017 12:46
    ​I would recommend that you consider obtaining a Certificate to Foreign Government (CFG) from FDA pursuant to section 801(e) of the FD&C Act.  CFGs have FDA's special stamp/seal.

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    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
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    Original Message


  • 3.  RE: Documentation for foreign markets

    Posted 15-Jun-2017 12:54
    Thanks.  That is one of the documents (actually a CoPP) that the market needs, however for some other things, like a price declaration or plant profile, they ask for a MOH stamp or certification.  Not certain how to handle that.

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    Marcy Sussman RAC

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    Original Message


  • 4.  RE: Documentation for foreign markets

    Posted 16-Jun-2017 09:25
    Marcy,

    like a price declaration or plant profile, they ask for a MOH stamp or certification

    For products going to Middle East,

    Please try Chamber of Commerce in your area (Maryland?) and also it is working making a call to the State's MOH as well!

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 5.  RE: Documentation for foreign markets

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jun-2017 08:53
    This message was posted by a user wishing to remain anonymous

    Since you do not indicate what type of product or what market, I'm not sure this is correct.  However, he CFG will not work from my understanding as it is actually a license provided by an independent entity that certifies the facility meets the outlined requirements.  I have never encountered it in nearly 50 countries, but we produce a medical device, not a pharma product, we are not a lab, and we are not a healthcare facility.
    The CFG is just a rubber stamped document where the FDA acknowledges you are exporting said products to a foreign country.  You fill it out, and they seal it and return it so it is definitely not a certification of any type.  I only located MOH certification companies in New Zealand and Singapore in my search as well as a reference to such licensing in Latin America.

    Good luck!
    Original Message


  • 6.  RE: Documentation for foreign markets

    Posted 16-Jun-2017 10:40
    You may also want to contact an apostille service in your state or in DC.  They are often experienced in a wide range of government stamps and certifications.

    I know one individual who wasted 3 days in lines at an embassy before he got his document stamped due to early closings and extended lunch hours there.  Using an apostille service can save a lot of time and is well worth the cost.

    Good luck!

    PS: Please post your attempts and method for success once you get this issue resolved so we can all learn from your experience.  Details like the exact certificate required, what stamp you acquired, and whether or not the country is a member of the Hague Convention may help some of us in the future.  Thanks.

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    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    john@johnminier.com
    1(914)850-4432
    Highland Mills, NY
    United States
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    Original Message


  • 7.  RE: Documentation for foreign markets

    Posted 19-Jun-2017 02:28
    For Middle East countries, please check with your counterpart, whether it MOH Stamp or "Company Stamp"; Even if they clarify you that it as MoH stamp, explain through a signed declaration letter and company stamp on it.

    Good luck!

    Regards
    Sreenu

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    SATTU Sreenu
    Regulatory Affairs Manager
    Singapore
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    Original Message


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