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Law of 11 September 2015 on amending the law on medical devices and certain other laws
Ustawa z dnia 11 września 2015 r. o zmianie ustawy o wyrobach medycznych oraz niektórych innych ustaw
Type
Law (Ustawa)
Status
in force (obowiązujący)
Announced
2015-09-11
Entry into force
2016-02-20
Texts
The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.
Keywords
Pharmaceutical Lawresearch and certificationMedical Productssupervisionregistersmedical activitiesbezpieczeństwo produktówmedical documentation
Related acts
Acts Declared Repealed (10)
- Announcement of the Minister of Health of December 17, 2015, on the announcement of the consolidated text of the Regulation of the Minister of Health on the method of making notifications and communications regarding medical devices · 2016-02-20
- Regulation of the Minister of Health of October 17, 2014, amending the regulation on the method of making notifications and reports concerning medical devices · 2016-02-20
- Regulation of the Minister of Health of January 12, 2011, on essential requirements and conformity assessment procedures for medical devices · 2016-02-20
- Regulation of the Minister of Health of March 31, 2011, on the detailed requirements that entities applying for authorization for notification in the field of products should meet, and the manner of supervision and control of notified entities · 2016-02-20
- Regulation of the Minister of Health of February 11, 2011 on requirements concerning the handling of essential clinical trial documentation · 2016-02-20
- Regulation of the Minister of Health of February 2, 2011 on criteria for reporting incidents with medical devices, the method of reporting medical incidents and device safety measures · 2016-02-20
- Regulation of the Minister of Health of 28 October 2011 amending the regulation on the amount of fees for notifications and announcements regarding medical devices and the amount of the fee for submitting an application for a free sale certificate · 2016-02-20
- Regulation of the Minister of Health of 15 November 2010 on the forms of applications submitted in connection with a clinical trial, the amount of fees for submitting applications, and the final report on the conduct of a clinical trial · 2016-02-20
- Regulation of the Minister of Health of 18 October 2010 on the method of making notifications and reports concerning medicinal products · 2016-02-20
- Regulation of the Minister of Health of September 22, 2010, on the amount of fees for notifications and communications regarding products and the amount of the fee for submitting an application for a free sale certificate · 2016-02-20
Amended Acts (7)
- Law of April 28, 2011, on the health protection information system · 2016-02-20
- Law of April 15, 2011, on healthcare activities · 2016-02-20
- Law of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products · 2016-02-20
- Law of May 20, 2010 on medical devices · 2016-02-20
- Law of January 29, 2004, on the Veterinary Inspectorate · 2016-02-20
- Law of 30 August 2002 on the conformity assessment system. · 2016-02-20
- Law of September 6, 2001, Pharmaceutical Law. · 2016-02-20
Acts referring to this act
- Amending Acts: Law of April 15, 2011, on healthcare activities
- Amending Acts: Law of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Amending Acts: Law of April 28, 2011, on the health protection information system
- Amending Acts: Law of May 20, 2010 on medical devices
- Amending Acts: Law of January 29, 2004, on the Veterinary Inspectorate
- Amending Acts: Law of 30 August 2002 on the conformity assessment system.
- Amending Acts: Law of September 6, 2001, Pharmaceutical Law.
- Repeals Resulting From: Regulation of the Minister of Health of 15 November 2010 on the forms of applications submitted in connection with a clinical trial, the amount of fees for submitting applications, and the final report on the conduct of a clinical trial
- Repeals Resulting From: Regulation of the Minister of Health of 18 October 2010 on the method of making notifications and reports concerning medicinal products
- Repeals Resulting From: Regulation of the Minister of Health of September 22, 2010, on the amount of fees for notifications and communications regarding products and the amount of the fee for submitting an application for a free sale certificate
- Repeals Resulting From: Regulation of the Minister of Health of February 2, 2011 on criteria for reporting incidents with medical devices, the method of reporting medical incidents and device safety measures
- Repeals Resulting From: Regulation of the Minister of Health of October 17, 2014, amending the regulation on the method of making notifications and reports concerning medical devices
- Repeals Resulting From: Regulation of the Minister of Health of 28 October 2011 amending the regulation on the amount of fees for notifications and announcements regarding medical devices and the amount of the fee for submitting an application for a free sale certificate
- Repeals Resulting From: Regulation of the Minister of Health of March 31, 2011, on the detailed requirements that entities applying for authorization for notification in the field of products should meet, and the manner of supervision and control of notified entities
- Repeals Resulting From: Regulation of the Minister of Health of February 11, 2011 on requirements concerning the handling of essential clinical trial documentation
- Repeals Resulting From: Announcement of the Minister of Health of December 17, 2015, on the announcement of the consolidated text of the Regulation of the Minister of Health on the method of making notifications and communications regarding medical devices
- Repeals Resulting From: Regulation of the Minister of Health of January 12, 2011, on essential requirements and conformity assessment procedures for medical devices