Malaysia Medical Device Regulations


It is a specific standard of quality management for medical device manufacturers.

Specifies requirements for a system of quality management that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and related services.

So this rule applies not only to companies that produce and serve, with respect to medical devices, but also to organizations that perform distribution and use of them.

Standard is based on ISO 9001 and includes other requirements specific to this sector.

Besides important terms are defined as medical devices, medical devices assets active medical devices implanted sterile medical devices and more.

It is the most widely accepted international standard among medical device manufacturers as it provides a base model for compliance with European directives ( -80 681 ) Regulations Canada Medical Device, and other regulatory requirements in countries located around the world.

For more detailed information see here

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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