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source: https://www.linkedin.com/groups/78665/78665-6343475714100064259 Marked as spam
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Could you ask the question a different way, I don't understand what you're asking. Are you saying a product is (a) registered in China but (b) the manufacturer is based elsewhere and discontinues manufacturing? If the question is that straightforward, I would say no, you can't sell what they don't make.
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Sidahmed Tadjer
Hi Joe, thank you for your aswer. The manufacturer is European. He stopped the european marketing of the product but continue to manufacture it specialy for Chinaese market. the manufacturer want to discontinue the CE marking of the product.
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Sidahmed Tadjer
Hi Jo,
I tried to collect advices of different specialists. The information I collected from some of them is that the registration process in China and in Europe are independent. The registration of medical device in China is requiring a free sell certificate (for this, the product must be CE marked) but when a product is registered in China the manufacturer can sell it until the end of the registration license whether the CE marking is steel available or not. The problem I have with this logic is that when the manufacturer registers the product, a technical file is communicated to Chinese authority with the CE certificate of the product and FSC. If the manufacturer stops the CE marking, the technical file is not the same. I don’t know if this change (stopping CE marking) is considered as substantial for the CFDA or not. And also, if this change question the validity of the license. Sorry if I am not clear. Regards Marked as spam
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THX...I agree with Sidahmed....if the product is no longer made in the US or EU and sold in China....the FSC and country of origin requirements are different than when the product was initially registered in China, so once the inventory in China is exhausted, no more products can be sold in China theoretically....however, if the customs officer isn't told about these changes, they still may let some products into China, using the old approvals,etc. However, this is not a good way to do business...thx,ames
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Arthur Brandwood
The practicalities of the CFDA process are that once in phase the registration grenadine valid irrespective of International changes. So all is well... until renewal comes around 5 years later.
Separately, CFDA have just proposed *removing * country of origin approval requirements for designated Innovative Devices. The notion is to open a pathway for new technologies to go to China first. See http://brandwoodbiomedical.com/streamlined-cfda-review-process-new-opportunities-in-china/ Marked as spam
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Yes, this happens all the time. Going back to the early 1970’s when a US Nutritional company had a baby formula that did not meet adequate standards and was removed from US market, it continued to be sold in other countries. Blood glucose monitors , for people with diabetes, may have a different name than the US version or even not be available in US market. Same for insulin pumps and I am sure many other medical devices. I would caution that such equipment may in fact be “Fraudulant”. In that such devices are not truly manufactured by the company but are actual copy cats. If any medical device is not being sold directly by the manufacturer or an agent of the manufacturer
I would be concerned about legitimacy. Marked as spam
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Diana Downs
I'm not sure what you mean by this. Had the company been required to stop manufacturing? Has there been a recall or market pull?
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Dave Sheppard, CMAA
The easiest way would be to find a good China partner and I'm sure multiple solutions can be achieved.
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Cornelio Florian
But if you know of any risk or possible harm to your customers, you should stop immediately distributing this specific device on your own.
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