China Medical Devices review

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Device classification approved by regulatory authorities

Chinese examination and approval of medical devices work, is a comprehensive supervision by the State Council of food, health products, cosmetics safety management and institutions directly under the charge of drug regulation - the State Food and Drug Administration (State Food and Drug Administration Bureau, SFDA), and the council subordinate units are responsible for the local. Medical devices must also obtain the import license approval (Import Device License Approval) and the Chinese local production equipment permit approval (Local Manufacturing Devices License Approval), in order to obtain approval of registration. Enter China's first, two, three (Class I, II, III) medical devices as well as local production of a third class (Class III) medical devices is determined by the SFDA direct audit; while the local production of the first, second (Class I, II) Class I medical devices, the local level by the review and approval by the relevant subordinate units.

Accreditation procedures

Accreditation process for medical devices there are three main steps:
制訂產品技術規範 1. Developing product specifications
完成產品測試 (2) completion of product testing
檔案審查與批准 3 file review and approval

Product Specifications

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

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 foreign laboratory test report issued some items, such as electrical safety IEC 60601-1 reported 110 projects, of which 61 projects are acceptable foreign laboratory test reports issued.

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

Ava the Elephant Ava the Elephant Talking Children's Medicine Dispenser
Baby Product (Ava the Elephant)
  • Included dropper is filled with the desired medicine, Protected by a US patent with an additional patent pending, Registered by the FDA as a class 1 medical device...
2013-01-11 11:58:15 by flaveur

GM moved x-ray division to China -- no medical

Device excise tax.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
Pete Yonkman, executive vice president of strategic business units at the Bloomington-based medical device company told the Indianapolis Business Journal that the company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013.
At least three firms have already announced layoffs in anticipation of the tax, including Michigan-based Stryker Corp, a maker of hip and knee replacements that said it will cut its work force by 5 percent, losing 1,000 jobs

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