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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.

Malta
Legislations
  1. Medicines Act, 2003 as amended by Act No. III of 2004
  2. Data Protection Act (2006)

Regulations
  1. Legal Notice 490: Clinical Trials Regulations, 2004 (Maltese)

Guidelines
  1. Guidance Notes on Good Clinical Practice (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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