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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.
Russia
Legislations
  1. Constitution of the Russian Federation, Article 21 (1993)
  2. On Medicinal Products, Federal Law No. 86-FZ, Articles 35-41 (2006) (1998 version in Russian)
  3. Federal Law of the Russian Federation on Information, Information Technologies, and Protection of Information (2006)
  4. Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006)

Regulations
  1. FSSHSD: Order No. 2314-Pr/07 17 on August 2007 about the Ethics Committee (Russian)
  2. MOH: Ministry of Health Order No. 103 (March 24, 2000)
  3. MOH: Clinical Practice Rules in the Russian Federation, Minister’s Decree #266 (2003)
  4. GOST: Good Clinical Practice. GOST-R 52379-2005 (September 27, 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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