0A4F4F9BD490A749D5437F821CF06DF1
IMDRF: Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects- Good Clinical Practice”
http://www.imdrf.org/docs/imdrf/final/procedural/imdrf-proc-150326-statement-iso141552011.pdf
http://leaux.net/URLS/ConvertAPI Text Files/53ADB9830F3675C5E9A7637B28A6A63B.en.txt
Examining the file media/Synopses/53ADB9830F3675C5E9A7637B28A6A63B.html:
This file was generated: 2020-07-15 08:05:16
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Drug Usage | drug | 2 |
Health / Drug Usage
Searching for indicator drug:
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p.(None): International Medical Device Regulators Forum
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Title: Statement regarding Use of ISO 14155:2011 “Clinical investigation of medical devices
p.(None): for human subjects – Good clinical practice”
p.(None):
p.(None): Authoring Group: IMDRF Management Committee
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p.(None): Date: 26 March, 2015
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p.(None): Toshiyoshi Tominaga, IMDRF Chair
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p.(None): This document was produced by the International Medical Device Regulators Forum. There are no restrictions on the
p.(None): reproduction or use of this document; however, incorporation of this document, in part or in whole, into another
p.(None): document, or its translation into languages other than English, does not convey or represent an endorsement of any kind
p.(None): by the International Medical Device Regulators Forum.
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p.(None): Copyright © 2015 by the International Medical Device Regulators Forum.
p.(None):
p.(None): IMDRF/MC/N25FINAL:2015
p.(None):
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p.(None): Use of ISO 14155:2011 “Clinical investigation of medical devices for human subjects – Good clinical practice” in each
p.(None): jurisdiction
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p.(None): Australia
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p.(None): Therapeutic Goods Administration (TGA)
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p.(None): Brazil
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p.(None): National Health Surveillance Agency (ANVISA)
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p.(None): Canada
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p.(None): Health Canada (HC)
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p.(None): China
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p.(None): China Food and Drug Administration (CFDA)
p.(None): As is common to all standards for devices, compliance with ISO14155:2011 is not mandatory, and the sponsor of a device
p.(None): is free to choose to demonstrate conformity to the Essential Principles (including EP 14 – Clinical Evidence) by other
p.(None): means such as by using clinical evidence from literature, or using data from trials which are not compliant with ISO
p.(None): 14155:2011. However, if alternative methods are used to demonstrate compliance with the Essential Principles, then a
p.(None): sound justification must also be provided. If a trial for a device complies with ISO14155:2011, then EP14 is deemed to
p.(None): be satisfied.
p.(None): The ISO 14155:2011 is one of the main references to the Resolution RDC n 10/2015 published on March 3rd, 2015 for
p.(None): clinical trials involving medical devices, particularly for Good Clinical Practice topics.
p.(None): The ISO14155:2011 is also referenced in the text of the Brazilian guidance as a standard to be followed in clinical
p.(None): trials audits.
p.(None): HC publishes a list of recognised standards to facilitate the regulatory review of medical device license applications.
p.(None): Included on the list is the standard entitled "Clinical investigation of medical devices for human subjects – Good
p.(None): clinical practice" (ISO 14155:2011/Cor.1:2011.). In Canada, conformance to particular standards are not mandatory
p.(None): requirements, but can be used as part of the evidence to demonstrate compliance with the requirements of medical
p.(None): devices regulations. In general practice, during review HC will typically utilize the criteria from the ISO14155:2011
p.(None): standard to question license applicants regarding the validity of a clinical study conducted in a country that do not
p.(None): have equivalent regulatory and Institutional Review Board (IRB) oversights to those in North America.
p.(None): While this standard specifically excludes In vitro diagnostic medical devices, several elements within ISO 14155:2011
p.(None): are considered to be relevant (e.g. planning, ethical considerations, conduct of the study, responsibilities, etc. ).
p.(None): In 1997, China released the medical device industry standard: YY/T 0297-1997, which was equivalent to the ISO
p.(None): 14155:1996, and it is a recommended standard, not a mandatory standard. In China, the clinical trials of medical device
p.(None): should comply with the requirements of the provision on medical device clinical trials (SFDA decree No.5) now. CFDA
p.(None): started to draft the medical device GCP(good clinical practice), during the process, we considered the requirements of
p.(None): new version of ISO 14155.
p.(None):
p.(None):
p.(None): 26 March 2015
p.(None): Page 2 of 4
p.(None):
p.(None): IMDRF/MC/N25FINAL:2015
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p.(None): Europe
p.(None):
p.(None): European Commission (EC)
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p.(None): Japan
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p.(None): Ministry of Health, Labour and Welfare (MHLW)
p.(None): Pharmaceuticals and Medical Devices Agency (PMDA)
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p.(None): Russia
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p.(None): Russian Ministry of Health Roszdravnadzor
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p.(None): The United States of America
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p.(None): US Food and Drug Administration (US FDA)
p.(None): The European regulatory system for medical devices includes legal requirements for clinical investigations, where
p.(None): harmonized standards provide presumption of conformity with the important aspects. EN ISO 14155:2011 [Clinical
p.(None): investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)] is a European harmonized
p.(None): standard, which provides broad presumption of conformity with the relevant legal essential requirements on clinical
p.(None): investigation, covering also aspects of good clinical practice (GCP) for medical devices. The use of this standard
p.(None): therefore provides one solution for compliance with those legal provisions. Compliance with the legal requirements can
p.(None): however be ensured also by other means.
p.(None): The Ministerial Ordinance No. 36 in 2005 is the medical device GCP in Japan, which aligns with ICH-GCP. Clinical trial
p.(None): data obtained from clinical trials outside of Japan have been accepted as a part of application dossier when all of
p.(None): the following are met: i) the standards for conducting clinical trials have a legal basis in the country or region
p.(None): where the trials were performed, ii) the standards are equivalent to or more complete than medical device GCP in Japan,
p.(None): and iii) the clinical trials were conducted in accordance with the standards or considered to be of equivalent quality
p.(None): as required with the standards.
p.(None):
p.(None): In this context, the guidance for the Japanese medical device GCP issued in February 2013 (No. 0208-1) clearly states
p.(None): that ISO 14155:2011 is an equivalent standard to the Japanese GCP.
p.(None):
p.(None): It is noted that GCP inspections (desk-top or on-site inspection) are applied even if the clinical trials are conducted
p.(None): in accordance with ISO 14155: 2011 or other equivalent standards.
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Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Drug Usage | drug | 2 |