Medical Diagnostic Devices China

Timeline of medicine and medical technology

The Medical Devices Directive (MDD) applies to all medical devices generally not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.

In order to comply with the MDD, you need to categorize your products correctly. The MDD divides the products into different classes based on risk and intended use, which again determines the conformity assessment procedure. For products classified as medium to high degree of risk, MDD requires conformity assessment procedure involving a notified body, such as DNV Business Assurance.

How DNV Business Assurance can help you?

DNV Business Assurance has been appointed as a notified body for all medical equipment with quality modules of Medical Devices Directive, Annexes II, V and VI. We are able to assess and certify their quality system so that you can attach the CE mark on its products according to the MDD.

The CE Mark is a requirement in order to sell products and medical devices in the European Union. In addition, a growing number of other markets require the CE ..

The DNV Business Assurance services include:

  • Technical documentation and dossier evaluation
  • Quality assurance equivalent to ISO 13485

We make evaluations of EC customer premises. Also provide guidance and interpretation of the policy, related to its products in particular, and provide training to a better understanding of the policy.

DNV Business Assurance is a member of the European Association of Notified Bodies for Medical Devices. We have 25 offices around the world, who are involved with the CE marking of medical devices.

Contact us to proceed with the classification and certification of products.

ICON Group International, Inc. The 2013-2018 Outlook for Medical Devices and Diagnostics in Greater China
Book (ICON Group International, Inc.)
2007-04-28 10:27:24 by -

But thanks to Bush

Other countries will pass us in stem cell research, which could be one of the biggest medical breakthroughs in generations
Most aircraft orders are now from foreign carriers, like China, which have 'local content' rules that force Boeing and Airbus to build the planes in the purchaser's country.
"a variety of scientific equipment and devices" can be and are made anywhere

2010-09-12 16:52:10 by fun_with_magnets

Patents enforcement keep knock-offs out

Really what they are talking about is having low-grade technicians reverse engineer existing products and find ways of cutting costs in manufacturing them. These products all have a lot of patents. A patent lasts for 17 years, which is longer than the useful life of most medical devices. that keeps cheap reverse-engineered knock-offs made in India or China from being sold in the developed world. If they want to use these products to improve their own health care, they can. But maybe they should try improving their roads, sewer systems and environment. That would improve the health of their people more

2002-10-01 12:52:10 by kemosabe_

Unions as a cure-all well,

No, they are not, but you should support those efforts, even if occasionally over-the-top, to alter the imbalance of power between worker (regardless of collar e.g. blue, white) and management.
Your suggestion that the price of goods eg. tennies and incomes have some absolute relationship is false. But here's where it gets interesting:
I'm not even refuting that argument here. I'm arguing a larger point. You see, if you have a family earning a living wage wherein they can afford to own a home/land, savings (for retirement, medical, future)and calorically sufficient diets AND
enough non-work time between them (to ensure good parenting, community involvement,personal enrichment then you have arrived at a desirable Quality of Life Standard

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