Analysis of safety reporting requirements during medical device clinical trials in Japan-Reference-Cited by-同舟云学术

Analysis of safety reporting requirements during medical device clinical trials in Japan

Published:2013-02-15 Issue:2 Volume:16 Page:234-241
ISSN:1434-7229
Container-title:Journal of Artificial Organs
language:en
Short-container-title:J Artif Organs

Author:

Azuma Kentaro,Iseki Hiroshi

Publisher

Springer Science and Business Media LLC

Subject

Cardiology and Cardiovascular Medicine,Biomedical Engineering,Biomaterials,Medicine (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1007/s10047-013-0692-6.pdf

Reference20 articles.

1. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) website. http://www.ich.org/ . Accessed 3 Dec 2012.

2. Global Harmonization Task Force (GHTF) history, International Medical Device Regulators Forum (IMDRF) website. http://www.imdrf.org/ghtf/ghtf-history.asp Accessed 3 Dec 2012.

3. IMDRF Ottawa Meeting Outcome Statement. Nov 2011. http://www.imdrf.org/docs/imdrf/final/meetings/imdrf-meet-111101-ottawa-outcome-statement.pdf . Accessed 8 Jan 2013.

4. About IMDRF, IMDRF website. http://www.imdrf.org/about/about.asp . Accessed 8 Jan 2013.

5. GHTF Chair. GHTF Closing Statement. Nov 2012. http://www.imdrf.org/docs/ghtf/final/media-releases/ghtf-closing-statement-121101.pdf . Accessed 8 Jan 2013.

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