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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.

Thailand
Legislations
  1. Consumer Protection Act (2007)     
  2. Official Information Act, B.E. 2540 (1997)
  3. National Health Act, B.E. 2549 (2006)

Regulations
  1. NCRT: Regulation on the Permission of Foreign Researchers (1982)
  2. MCT: Rule of the Medical Council on the Observance of Medical Ethics (2006)

Guidelines (MCT):
  1. National Guideline for Ethical Research on Human Subjects (2002)
  2. The Ethical Guidelines for Research on Human Subject in Thailand (2007)
  3. Thailand Good Clinical Practice Guidelines (2002)
 
 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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