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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.

Malawi
Legislations
  1. Presidential Decree on 30th March 1974
  2. Malawi Government Gazette, June 11, 1976, General Notice No. 398
  3. Pharmacy, Medicines, and Poisons Act, Act 15 of 1988
 
Regulations
  1. NRCM: Procedures and Guidelines for the Conduct of Research in Malawi (2002)

Guidelines
NHSRC:
  1. Operational Guidelines (2001)
  2. Summary Guidelines for Writing Research Proposals (2001)
COMREC:
  1. Research Guidelines (2004)
 
 


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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