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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :International Compilation of Human Research Protections 2010 Edition.. 2009-12-23 22:59:39 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Dear Friends.

The 2010 version lists about 1,100 laws, regulations, and guidelines on human subject protections from 96 countries. This year’s Compilation includes listings from 5 new countries: Dominica, Guatemala, Honduras, Kyrgyzstan, and Qatar.


Many of the listings include the web address, allowing the reader to link directly to the law, regulation, or guideline of interest.


Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world.

You can reach the version by clicking here or from this link: http://www.hhs.gov/ohrp/international/HSPCompilation.pdf

Kind regards,

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