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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.
Poland
Legislations
  1. Constitution of the Republic of Poland, Article 39 (1997)
  2. Medical Profession Act, Articles 21-29 (1997)
  3. Pharmaceutical Law, Act of Sept. 6, 2001, Article 6
  4. Law of 20/04/2004 on Amendment of the Pharmaceutical Law, Law on the Profession of Medical Doctor, and Regulations Introducing the Pharmaceutical Law, Law on Medical Devices, and Law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Journal of Laws No. 92, Item 882)
  5. Act on the Protection of Personal Data (2006)
 
Regulations
  1. MOH: Order of the Minister of Health and Social Welfare on How to Establish, Finance, and the Mode of Action of Bioethics Committees (1999)
  2. Order of the Minister of Health in the Matter of Central Register of Clinical Trials (2004)
  3. Decree of the Minister of Health on Clinical Trials on Minors (2004)
  4. Order of the Minister of Finance Concerning the Mandatory Civil Liability Insurance of Researchers and Sponsors (2004)
  5. March 11, 2005 Order of the Minister of Health Concerning Detailed Requirements of Good Clinical Practice (2005)

Guidelines
  1. SCD: Code of Medical Ethics, Chapter II (2003)
  		 


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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