Medical Devices Regulations 2010

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"Supervision and Regulation of Medical Devices"

Pinyin: "Yīliáo Qìxiè Jiāndū Guǎnlǐ Tiáolì" ("Yiliao Qixie Jiandu Ganli Taoli")

Synonym of: Medical Devices Regulations

State Council Order No. 276

(December 28, 1999 the 24th executive meeting of the State Council passed)

Issued: 20, 000, 104 Effective Date: 20000401 issued Unit: State Department

Medical Devices Medical Devices

Article 2 The People's Republic of territory in the medical device research and development, production, operation, use, supervision and management of the unit or individual shall comply with the regulations.

Article 3 The term medical equipment, used alone or in combination refers to any instrument, apparatus, appliance, material or other article, including the required software; it for the human body by pharmacological effect is not , immunological or metabolic means, but may have these means to participate and play a supporting role; their use is expected to achieve the following purposes:

(A) for disease prevention, diagnosis, treatment, monitoring, mitigation;

(Two) for an injury or disability diagnosis, monitoring, treatment, alleviation of or compensation;

(Three) on the anatomy or a physiological process studies, replacement or modification;

(Four) pregnancy control.

Article IV State Drug Administration is responsible for the country's medical device supervision and management.

Local people's governments above the county level drug supervision and administration department is responsible for the administrative area of ​​supervision and management of medical devices.

State Drug Administration departments shall cooperate with the State Department for comprehensive economic management departments, the implementation of the national policy of the medical device industry.

The state of medical devices of category management.

The first category refers to the Regulation, to ensure their safety and effectiveness of medical devices.

The second category refers to its safety and effectiveness of medical devices should be controlled.

The third category refers implanted in the body; used to support, sustain life; potentially dangerous to humans, its safety and effectiveness of medical devices must be strictly controlled.

Medical Devices Category departments by the State Drug Administration medical device classification rules based, commercial administrative department of health to develop, adjust, publish.

PharmaLogika Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations
Book (PharmaLogika)
2006-02-20 17:02:02 by Bioseeker

8 years in biotech

I've been working consistently in the biotech field, after a BA in Psychobiology for 8 years.
-Regulatory Affairs deals with getting FDA approval of new drugs and medical devices.
I went to the Biospace job fair last month but haven't got any calls. I'm wondering if its b/c I currently reside in LA. I'm thinking of moving down there and looking for something fast thru a temp agency. Any advice?

2009-01-11 15:13:59 by windshadow

More from hsi

Last month, a group of FDA scientists sent an SOS to Representative John D. Dingell, chairman of the House Committee on Energy and Commerce. The letter calls for "urgent intervention" due to "serious misconduct" by managers of the Center for Devices and Radiological Health (CDRH) – the FDA division that oversees everything from imaging equipment to breast implants.
So what constitutes "serious misconduct"?
Here's how the scientists put it: "There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices

2007-09-08 13:08:25 by -------

Chip implants shown to cause cancer, a

"When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats

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