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Thread: Importing lasers into U.S.

  1. #1
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    Default Importing lasers into U.S.

    Hi All,

    I could not really find any other thread related to this subject ( or perhaps I was just careless ) so here is a question for those who might have experiences with importing lasers into the U.S.
    Actually I have done some search on the internet and I think do have a basic knowledge of what documents are required - ILDA website - although I thought it would make sense to get in touch with those who have gone through the process before just to get an idea how things work and how long it takes, etc

    I would appreciate any comments / experiences you may be able to share.

    Are the regulations the same for temporary import ( i.e. a demo for a possible new customer ) as well ?

  2. #2
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    Trebors-

    Welcome to PL. There is a realistic answer to your question and d there is a politically correct answer. I will try to be as brief as possible...

    1. In the usa, lasers are regulated and 'controlled' by a branch of the FDA called the CDRH. The cdrh classifies lasers under non ionizing radiation emitting products. These regulations are covered by 21CFR PART 1040.10 21 CFR PART 1040.11 and 21 CFR PART 1010. The cdrh limits lasers operated in public to 4.9mW (milli watts). ANY LASER which emits visible or invisible laser light above 4.9mw must meet certain safety specs and also must be 'certified' by the cdrh.

    2. A 'certified' laser is a laser system in which its manufacturer prepared a detailed analysis, safety, design, engineering and quality control program to the cdrh. To be certified, the laser and manufacturer must adhere to many strict guidelines and safety stabnards governing lasers. What the manufaturer is doing is pretty much saying, here is the lasef system i am building. It has all of the following safety systems and adheres to 21cfr part 1040. Please allow me to build them and sell them.

    3. If the cdrh likes the way you designed the laser and they approve of the safety systems you have installed in the laser, they will issue you a "variance" allowing you to produce these systems as long as you stick to the report you submitted to the cdrh. (Known as an initial product report.).

    4. Once the product is approved and is 'allowed' to be brought into usa commerce, now the end user needs to apply for a variance to use that laser in public. If the product is not certified by the cdrh, than you will have to do a report and most likely modify the laser to be able to get it certified. If a laser is not certified, you will not be able to get a variance to operate it.

    5. Purchasing foreign laser systems, ESPECIALLY chinese systems is very risky because a) the quality is usually sub par. B) the safety is non existent (usually) and the biggest concern would be the laser being seized by customs.

    6. Chinese lasers and almost every other foreign laser co. (There are a few exceptions) do not have any laser products certfied in the usa. Therefore, technically they are illegal and being imported illegally. You *DO* have the very real possibility of losing your laser.

    Hope this helps. Feel free to email me or call me if you would like more info.

    -Marc
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  3. #3
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    Default

    Chinese lasers and almost every other foreign laser co. (There are a few exceptions) do not have any laser products certfied in the usa.
    Actually, there are some Chinese laser certified - I believe we confirmed here on the forum that Able are for some of their products.
    Frikkin Lasers
    http://www.frikkinlasers.co.uk

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  4. #4
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    Able laser does have a US variance. They can be safely imported.

  5. #5
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    If your importing for a demo, there is a form you can fill out if your a US Citizen, it states what it is, what your doing with it, why it does not comply, and that its LEAVING the country on a certain date.

    So if I (US Citizen) want to borrow a demo unit, I can fill out the form and have a supplier ship it as a demo. I just have to make sure it goes back out.

    If I remember right, it can be here for 364 days, but has to ship back, or else.... Thinking the form is FDA 2877 or FDA 766

    Steve
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  7. #7
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    I was going to start a new thread addressing this but found this one and figured I'd continue it. I was basically thinking about the very same questions this morning.

    "What are the steps necessary to legally import a non-compliant laser projector into the United States with the intention of reviewing it, taking the neccessary steps to make it compliant, completing a manufacturers product report and submitting it under your manufacturers variance and retain it for your own use under your show variance?"

    In carefully reading and following along FDA 2877, it appears this is possible, provided you are putting the horse before the cart and doing things in the correct order. I would think it has to be.

    What's throwing me a little is the issue of a temporary import bond. A temporary import bond is basically putting money up, that generally covers two times the amount of the duty (tax) that would need to be paid on importing your item if it were to stay here. The idea is that, you are importing something for the short term (usually a year) with the intent of shipping it back once you were done with it (or distroying it under customs supervision) - whether that is for a trade show or, for research or whatever. If you don't ship it back or destroy it within the allotted time, that bond is forefitted. (sp) If in fact, it is proved to be shipped back, the bond is refunded. But what if you just agreed to pay the duty?

    In the instructions for Form 2877 it states that, if an importer/broker intends to import equipment into the United States for purposes of research, investigations, studies, demonstrations or training but also wishes to retain the option of bringing the product into compliance with the performance standard, check Declarations C and D and insert the word "or" between the Affirmations. The US Customs Service will treat this as entry as a "D" Declaration for purposes of duty. In then goes on to describe that you then fill out form FDA 766 which is really your plan (length of time) (how you're bringing it into compliance)( why you need to use options C and D) etc.

    However... under "D", it states that the item will be held and remain under bond and will not be introduced into commerce until notification is received from FDA that products have been brought into compliance in accordance with an FDA approved petition (which is form 766).

    So, it sounds like to me, you basically need to get the temporary import bond and then, ultimately pay the duty later, once you have made it compliant and get the bond released.

    I'm just trying to figure out the correct order of everything if you're trying to do the right thing and be "above board" and legal on every last step.
    Last edited by Bradfo69; 11-13-2014 at 12:37.

  8. #8
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    In bulk, you would bring the widgets in declared as an OEM part. For a single widget, it is pretty much how you describe. PM me and I can send you emails/numbers of some people to talk to at the FED.

    Steve
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  9. #9
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    I imported from China, it's was delivered to my door a short time after it started shipping. I was tracking it online the whole time and was relieved when it landed in the US and made it through customs and on it's way towards me. My question is... What about the import tax? It's not something I payed ahead, or at the time of delivery, or even in the following over half year since I've received my pj. Is there a chance the form/bill never made it to my door, or is it safe to assume there was no fee?

  10. #10
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    China is out of the question nowadays, so I suppose Canada might also be an alternative.
    Any specific customs regulations to keep in mind?

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