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Thread: Seller's product certification requests?

  1. #21
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    Quote Originally Posted by taggalucci View Post
    This suggests a manufacturer outside the US could not apply for a Manufacturer's Variance. Is this true?
    No, the issue is that foreign manufacturers can apply for and obtain variances, and some even have, the problem is that the requirements are so high that it is just not worth it for most of them... especially when sneaking products in and making it your problem is marginally easy.

  2. #22
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    Surely they'd only have to do this once per model. And if they're after volume sales (which they clearly are) the cost of certifying per unit would be quite low.

    If they make units with similar base specs then couldn't additional models potentially just be extensions to a single Variance?

    CNI a Chinese company have variance documentation for some of their lasers I believe. I can't see why a Chinese laser projector manufacturer can't do a little more work and certify their projectors. Surely that would be a huge selling point and a point of difference from their own competitors.

  3. #23
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    I think another factor to consider is that all the Chinese manufacturers use parts that have limited availability windows.
    By the time they've managed to get a variance for a unit, they can no longer build that unit. In fact, the speed of progress in the solid state laser world, and in particular the small to medium size projector market means that any design is effectively superceded before a proper variance appears to be able to be granted.

    You try and find a Chinese manufacturer selling a projector the same as they were selling 2 years ago.

    And this is not just for Chinese manufacturers, I think it would affect any mass producing projector manufacturer using some non-proprietory parts
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  4. #24
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    That is not really the issue...

    First the entry barriers are extremely high including developing infrastructure for ongoing record keeping requirements. CDRH terms it is a "quality assurance process" which basically means making sure that projectors remain in compliance through their entire lives as previously certified. This is pretty difficult by itself, but there's more...

    21CFR1040 specifically states that unless you jump through 15 very expensive hoops, user maintenance - like alignment - is disallowed. So you are either faced with adding electrical, redundant housing interlocks and a bunch of other things which totally change your manufacturing process, or you have to tell your customers that they have to DHL their laser back to the factory every time it has to be cleaned or serviced.... which of course would never happen and cause your QA process to be disallowed resulting in a loss of your variance.

    So then the only other option is to open a US manufacturing facility to handle certification, service, etc. which of course is obscenely expensive and even if you do it then the US firm has to be set up as the manufacturer, be subject to the variance terms, etc. and even then they couldn't sell to anyone who didn't already have a variance which nearly completely eliminates their ability to do volume sales making the whole thing not cost effective.

    There's a lot more too, but that it perhaps the single biggest set of issues.

  5. #25
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    Sorry Norty, I wasn't responding to you when I was writing.

    Yes, that is another problem. Parts availability is very sticky.

  6. #26
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    I am SOOO glad I'm not living over there.

    To state the f**kin' obvious, despite doing it with the best intentions, they've got themselves so caught up in the red tape and beaurocracy, its made it sort of pointless.

    I feel for you guys and I hope they look at some sort of reform in the near future but it doesn't sound good.
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  7. #27
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    I wasn't aware if the lifetime compliance management requirements. To me that's a tad excessive. That's like making a car manufacturer responsible for solely providing ongoing maintenance facilities for ever car in every location they're in use, never mind preventing your customer from ever removing the seatbelts! Surely a non-manufacturer related, though qualified service centre could perform the same maintenance and keep the projector certified?

    If the hoops are too costly and difficult (within reason) to jump through then the CDRH/FDA are only contributing to the problem in my opinion. If you make compliance too hard to attain, then why bother making any of your projector compliant? I.e. If you're going to risk non compliance because you can't fulfill the lifetime QA, then why bother with an interlock? Not that I am recommending this.

    As for parts obsolescence, surely the components don't have to be exactly the same (part numbers) but should simply fulfill the same capabilities, power ranges, wavelengths etc?

  8. #28
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    Well there is a slight distinction I would draw there which is that:

    1) The manufacturer is not required to keep the product working for its entire life, it is required to keep it COMPLIANT for its entire life. So, if the laser dies after two weeks the product is still compliant because it is non-functinal. I personally think that that is a reasonable requirement. If someone chooses to recertify a product having been rebuilt at a later date, then they become the new manufacturer.

    2) Part of the issue with any given projector is that we tell the FDA how it is built, and what tests we perform to ensure it is built properly. An service center would have to follow that same procedure, and keep records of the results of those tests, in order to keep the product compliant as originally made. Because there are no manufacturing or service standards in the industry as a whole, standardizing that process is almost impossible across manufacturers. Then, who determines who is "qualified?" Its a problem so people break the rules, everyone gets legal heartburn and more rules are made.

    I hate to tell you guys but it is not just FDA. IEC is very similar in many respects. The primary difference is how and to what extent it is enforced in each jurisdiction. Our products are actually mostly certified under the harmonized IEC/FDA rules laid out in 60825-1.

  9. #29
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    Unfortunately SOME laser manufacturers are not really Manufacturers... they just try to take someone elseís box, put some lasers and scanners in it and call it legal... Well that is NOT the case. YOU MUST BE A MANUFACTURER ON RECORD... YOUR VARIANCE MUST STATE THAT YOU ARE ABLE TO MANUFACTURER LASER PROJECTORS, AND NOT JUST LASER SHOWS. If you are not a manufacturer on record, you are just the same as all this Chinese companyís trying to sell their lasers with certifications that do not exist.

    I AM a CERTIFIED MANUFACTURER, and am getting tired of everyone thinking they can just slap together a projector and call it legal... Even if I were to sell you an enclosure, unless you are a Manufacturer, you cannot put lasers into it and call it legal. You wouldn't even believe the projectors I have seen that people are claiming are legal... even some built by respected fellow PL members that sell projectors, putting no case interlocks on class 4 lasers, no restart, and selling them to other board members.... NOT COOL!!!

    And another thing, DO NOT TRY TO UPGRADE YOUR CLASS 3B laser to a CLASS 4!!!! It is then going to be ILLEGAL and you might as well have bought a cheap Chinese projector if you are going to be illegal.

    It is time for all the US members of PL to take a stand, and FOLLOW THE RULES!!! If you are going to do a show, have a variance and send in the show notification. If you are going to build projectors, GET YOUR MANUFACTURING VARIANCE, spend the money and time that us LEGAL manufacturers have done, and make a product report, a userís manual, put restart's on class 4 lasers, put housing interlocks on class 4 lasers.... GET A CLUE!!!!! QUIT SAYING IT IS A GREY AREA, it is clearly spelled out in blue, black, and white.... you can read it all here
    http://www.fda.gov/MedicalDevices/De.../ucm094445.htm

  10. #30
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    I started this thread to get a discussion going and I appreciate that professional input but I have to state something. I just built a projector that incorporates all the safety features of a class IV projector (interlock circuit with redundant case intrusion sensors, manual reset button, safety shutter and key lock) and just sent in my product and show report as a manufacturer, after speaking with several laser safety specialist about my projector AND paperwork... It is NOT that hard. If I can do it... It can't be TOO HARD at all.

    I think all the projectors being sold by overseas manufacturers and imported to the US should be done so legally, but I don't think anyone should be scared into thinking it is a lost cause to not only get your own projector compliant or getting overseas manufacturers from manufacturing compliant projectors.

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