Register Medical Device China

Autoclave, Dental Autoclaves, Steam Sterilizers Manufacturer

Device classification approved by regulatory authorities

Approval Process

Medical device approval process has three main steps:

1. Developing product specifications
(2) completion of product testing
3 file review and approval

Product Specifications

Samples to test, according to SFDA must first requirement specifications for each product formulation. Write specification, reference should be of similar products have been published by the International Standards (GB) standards, or in accordance with the requirements specified industry. Most of the current GB standard is based on IEC and ISO.

Test requirements

Sample test must be approved by SFDA and the specified test agencies. Each test agencies based on their individual experience and expertise with a special, different tests assume responsibility. During the test, China testing agencies authorized to acknowledge and accept credit reliable and internationally renowned test report issued by a foreign laboratory part of the project. For example, electrical safety IEC 60601-1 reported 110 projects, of which 61 projects are acceptable test reports issued by a foreign laboratory.

Please note that during the test, the applicant or his agent must be registered with the testing agency officials to establish a very close clear communication mode. Testing agency of any specific advice, must immediately get a reply. The two sides must not have any misunderstanding or misunderstanding, to avoid execution error testing and / or omissions quite prone to important tests. If there are any in the communication misunderstanding, not only will lose valuable time, and sometimes even cause the entire testing process over again.

In addition, the first category of products to apply for import and local production license approval, no need for sample testing.

High-risk devices - Clinical Trial

The new specification for high-risk medical devices, innovative design products in the finished product testing, prior to applying for registration with the SFDA, another step must be carried out, such as clinical trial to verify the product's effectiveness and safety. SFDA clinical trial must be approved and designated hospitals, but because every hospital has a different experience and expertise, so that different hospitals will be responsible for the different types of clinical trial norms. All clinical trials must strictly abide by Chinese Good Clinical Practice (Good Clinical Practice, GCP) requirements.


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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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