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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.
Costa Rica

Legislations

  1. Law 5395, General Health Law, Articles 64-68 (1973) (Spanish)


Regulations

  1. CONIS: Executive Decree No: 31078-S (2003) (Spanish)
  2. CCSS: Regulation of Clinical Investigation in the Assistance Services of the Social Security Fund (2005)


Guidelines (CONIS):

  1. Ethical and Legal Principles
  2. Duties and Responsibilities of the National Council on Health Research, of Investigators, and of the Sponsor
  3. Structure and Functioning of the Committee Network
  4. Design of the Research Protocol
  5. Requirements for the Submission of a Research Protocol
  6. Informed Consent
  7. Approval and Follow-up of a Research Project
  8. Sanctions
  9. Guidelines for Good Clinical Practice (1996)
  10. Protocol for Clinical Trials
  		 


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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