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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.
Vietnam

Legislations

  1. Decision No. 2626/QD-BYT on Promulgation of the “Procedure of Organizing and Functioning Ethical Committee for Bio-Medical research, Mission 2008 – 2012” (2008) (Vietnamese)


Regulations

  1. Regulation on Clinical Trials (2007)
  2. Decision No. 799/QD-BYT of the Minister of Health on the Promulgation of the “Guidelines on Good Clinical Practice of Clinical Trials” (2008)
  3. Decision No. 23 /2008/QD-BYT of the Minister of Health on the Promulgation of the “Regulations on Utilization of Vaccine and Medical Immuno-Biological Products in Prevention and Treatment” (2008)


Guidelines

  1. Guidelines on Good Clinical Practice of Clinical Trials (2008)

 
  		 


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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