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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.

China, People's Republic of


  1. Law on Practicing Doctors (June 26, 1998), Articles 26 and 37
  2. Drug Administration Law (2001)
  3. Hong Kong: Personal Data (Privacy) Ordinance (1996)


  1. Chinese Good Clinical Practice (2003) (Mandarin)
  2. Qualification and Evaluation of Clinical Trial Sites
  3. Regulation on Drug Registration (2007)


  1. Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2007) (Mandarin)
  2. CAST: Moral Standards for Scientists (2007)
  3. Guideline for HIV Vaccine Research Technology (2003)

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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