p**********9
发帖数: 3463 | 1 爸爸在国内负责这方面的生产, 想开发一些新产品,地面用品(什么床单啦)消毒, 身体消毒,器械消毒的.(他们有生产84消毒液、络合碘,强化戊二醛、抗菌液). 想了解美国的配方和中国有什么不同? 有什么地方可以找到相关资料么? 谢谢. | s**********8
发帖数: 25265 | 2 不太了解啊
【在 p**********9 的大作中提到】
: 爸爸在国内负责这方面的生产, 想开发一些新产品,地面用品(什么床单啦)消毒, 身体消毒,器械消毒的.(他们有生产84消毒液、络合碘,强化戊二醛、抗菌液). 想了解美国的配方和中国有什么不同? 有什么地方可以找到相关资料么? 谢谢.
| a*i
发帖数: 1652 | | W********t
发帖数: 8514 | | k****i
发帖数: 1126 | 5 消毒剂本身算medical device吗？
【在 W********t 的大作中提到】
: 需要510K的顾问吗？
| k****i
发帖数: 1126 | 6 举个例子？如果是消毒剂本身的话。
【在 W********t 的大作中提到】
: 需要510K的顾问吗？
| p**********9
发帖数: 3463 | 7 maybe it is not medical device. it is just related to medical products.
don't know where to post so posted here...hehe
【在 k****i 的大作中提到】
: 消毒剂本身算medical device吗？
| s**********8
发帖数: 25265 | 8 u r welcome to post here.
【在 p**********9 的大作中提到】
: maybe it is not medical device. it is just related to medical products.
: don't know where to post so posted here...hehe
| a*i
发帖数: 1652 | 9 germicidal wipes
【在 k****i 的大作中提到】
: 举个例子？如果是消毒剂本身的话。
| k****i
发帖数: 1126 | 10 不是抬杠,属技术讨论哈.
那些surgical device都是你说的critical device吗?那用来sterilize的东西算
medical device?
Semicritical
【在 W********t 的大作中提到】
: 需要510K的顾问吗？
| | | a*i
发帖数: 1652 | 11 Medical Device Definition
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
Medical devices range from simple tongue depressors and bedpans to complex
programmable pacemakers with micro-chip technology and laser surgical
devices. In addition, medical devices include in vitro diagnostic products,
such as general purpose lab equipment, reagents, and test kits, which may
include monoclonal antibody technology. Certain electronic radiation
emitting products3 with medical application and claims meet the definition
of medical device. Examples include diagnostic ultrasound products, x-ray
machines and medical lasers. If a product is labeled, promoted or used in a
manner that meets the following definition in section 201(h) of the Federal
Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug
Administration (FDA)4 as a medical device and is subject to premarketing and
postmarketing regulatory controls. A device is:
"an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component
part, or accessory which is:
recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
animals, or
intended to affect the structure or any function of the body of man or other
animals, and which does not achieve any of it's primary intended purposes
through chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement of any of
its primary intended purposes."
This definition provides a clear distinction between a medical device and
other FDA regulated products such as drugs. If the primary intended use of
the product is achieved through chemical action or by being metabolized by
the body, the product is usually a drug. Human drugs are regulated by FDA's
Center for Drug Evaluation and Research5 (CDER). Biological products which
include blood and blood products, and blood banking equipment are regulated
by FDA's Center for Biologics Evaluation and Research6 (CBER). FDA's Center
for Veterinary Medicine7 (CVM) regulates products used with animals. If your
product is not a medical device but regulated by another Center in the FDA,
each component of the FDA has an office to assist with questions about the
products they regulate. In cases where it is not clear whether a product is
a medical device there are procedures in place to use DSMICA Staff
Directory8 to assist you in making a determination. | k****i
发帖数: 1126 | 12 学习了。
【在 W********t 的大作中提到】
: 需要510K的顾问吗？
| s**********8
发帖数: 25265 | 13 good post. keep going.
【在 W********t 的大作中提到】
: 需要510K的顾问吗？
| W********t
发帖数: 8514 | 14 谢谢版大的支持和鼓励！
【在 s**********8 的大作中提到】
: good post. keep going.
| n***z
发帖数: 113 | | p**********9
发帖数: 3463 | 16 很高兴这么多人讨论, 爸爸又在电话了催了,哎呀, 有人 指点一下么? 觉得只有做这块
销售的才清楚. 我倒是有亲人都在美国医院工作, (护士和医生,还有药剂师),
可他们好象什么都不清楚啊.
【在 n***z 的大作中提到】
: 原来这里有专家啊
| a*i
发帖数: 1652 | 17 找胖猫了，呵呵
【在 p**********9 的大作中提到】
: 很高兴这么多人讨论, 爸爸又在电话了催了,哎呀, 有人 指点一下么? 觉得只有做这块
: 销售的才清楚. 我倒是有亲人都在美国医院工作, (护士和医生,还有药剂师),
: 可他们好象什么都不清楚啊.
| F******n
发帖数: 346 | | ot
发帖数: 4549 | 19 看看EcoLab的产品吧。差成分的捷径是找他们的label和MSDS
http://www.ecolab.com/businesses/pest/msds.asp
体消毒,器械消毒的.(他们有生产84消毒液、络合碘,强化戊二醛、抗菌液). 想了解美
国的配方和中国有什么不同? 有什么地方可以找到相关资料么? 谢谢.
【在 p**********9 的大作中提到】
: 爸爸在国内负责这方面的生产, 想开发一些新产品,地面用品(什么床单啦)消毒, 身体消毒,器械消毒的.(他们有生产84消毒液、络合碘,强化戊二醛、抗菌液). 想了解美国的配方和中国有什么不同? 有什么地方可以找到相关资料么? 谢谢.
| ot
发帖数: 4549 | 20 nope，连打交道的部门不一样。跟EPA而不是FDA打交道的。法律是40CFR, 29CFR而不是21CFR
【在 k****i 的大作中提到】
: 消毒剂本身算medical device吗？
| p**********9
发帖数: 3463 | 21 thanks. it is helpful.
【在 ot 的大作中提到】
: 看看EcoLab的产品吧。差成分的捷径是找他们的label和MSDS
: http://www.ecolab.com/businesses/pest/msds.asp
:
: 体消毒,器械消毒的.(他们有生产84消毒液、络合碘,强化戊二醛、抗菌液). 想了解美
: 国的配方和中国有什么不同? 有什么地方可以找到相关资料么? 谢谢.
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