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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.
Taiwan
Legislations
  1. Medical Care Act, Articles 8, 70, 78, 79, 80, and 98 (2004)
  2. Computer-Processed Personal Data Protection Law (1995)
Regulations
  1. DOH: Guideline for Good Clinical Practice (2005)
Guidelines (DOH):
  1. Ethical Guidelines for the Announcement of New Medical Knowledge or Research Report by Medical Institutes or Members (2001)
  2. Standards for the Organization of Human Trial Committees in Medical Care Institutions and their Operation (2003)
  3. Categories of Research that may be Reviewed by the Institutional Review Board (IRB) through an Expedited Review (2006)
  4. Announcement of Human Research Ethics Policy Guidelines (2007)
  5. Operational Guideline for Drug Clinical Trials (2002)
  6. Structure and Content of Clinical Study Reports (2003)
  7. The Criteria for IRB review (2004)
  8. Guidelines for Informed Consent Form of Pharmacogenetic Study (2005)
  		 


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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