Home / Dz.U. 2004 nr 120 poz. 1258
Regulation of the Minister of Health of April 30, 2004, on the form of the application for a permit to commence clinical trials of a medical device, the final report on the execution of such trials, and the form of the declaration of conformity of a medical device intended for clinical trials with safety requirements
Rozporządzenie Ministra Zdrowia z dnia 30 kwietnia 2004 r. w sprawie wzoru wniosku o wydanie pozwolenia na rozpoczęcie badania klinicznego wyrobu medycznego, sprawozdania końcowego z wykonania tego badania oraz wzoru oświadczenia o zgodności wyrobu medycznego przeznaczonego do badania klinicznego z wymaganiami w zakresie bezpieczeństwa
Type
Regulation (Rozporządzenie)
Status
not in force - legal basis repealed (nieobowiązujący - uchylona podstawa prawna)
Announced
2004-04-30
Entry into force
2004-05-28
Texts
Keywords
Medical Productsreportingdocumentsbezpieczeństwo produktówdeclaration
Related acts
Legal Basis (1)
Legal Basis from Art. (1)
- Law of 20 April 2004 on medical devices · art. 35 ust. 6
Repeals Resulting From (1)
- Law of May 20, 2010 on medical devices · 2010-09-18
Acts referring to this act
- Acts Declared Repealed: Law of May 20, 2010 on medical devices
- Implementing Regulations: Law of 20 April 2004 on medical devices
- References: Announcement of the President of the Polish Committee for Standardization of September 10, 2010, on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of 18 February 2010 on the list of harmonized standards