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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.
Tanzania
Legislations
  1. National Institute for Medical Research, Act of Parliament No. 23, of 1979
  2. Tanzania Commission for Science and Technology, Act No. 7 of 1986
  3. Amendment of NIMR Act 1997, Tanzania Government Gazette, No. 675
  4. Tanzania Food, Drugs, and Cosmetics Act, Sections 61, 66, 67, and 69 (2003)

Regulations (NIMR):
  1. Coordination of Health Research in Tanzania
  2. Coordination of Formation of Institutional Health Research
  3. Coordination of Research in Tanzania

Guidelines
NHREC:
  1. Guidelines on Ethics for Health Research in Tanzania (2001)
  2. Brochure for Health Researchers in Tanzania (2006)
  3. Committees to Formally Approve for Local Health Research
COSTECH: COSTECH Guidelines on Research Permits and Clearance (2006)
  		 


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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