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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.

Zimbabwe

Legislations

  1. Government Notice Act (1974)
  2. Research Act (1986)
  3. Medicines and Allied Substances Control Act, Chapter 15:03 (1997)


Regulations

  1. Medicines and Allied Substances Control Act, General Regulations (1991)


Guidelines

  1. Guidelines for Researchers and Ethics Review Committees in Zimbabwe (2004)
  2. Conducting Health Research in Zimbabwe: What Researchers Need to Know (2004)
  3. Statutory Instrument 150 of 1991
  4. Guidelines for Good Clinical Practice
 
 


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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