A Comparative Study of Medical Device Regulations: US, Europe, Canada, and Taiwan-Reference-Cited by-同舟云学术

A Comparative Study of Medical Device Regulations: US, Europe, Canada, and Taiwan

Published:2018-01 Issue:1 Volume:52 Page:62-69
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Chen Yi-Jung,Chiou Chi-Ming,Huang Yu-Wen,Tu Pei-Weng,Lee Yung-Chuan,Chien Chia-Hung

Funder

Food and Drug Administration

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479017716712.pdf

Reference17 articles.

1. BMI Research. Global medical devices report. http://www.espicom.com/global-medical-devices-report.html. Published July 2016. Accessed November 28, 2016.

2. US FDA. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Published January 2016. Accessed November 28, 2016.

3. European Commission. Proposed Medical Device Regulation (MDR). http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_11662_2016_INIT&from=EN. Published August 2016. Accessed November 28, 2016.

4. European Commission. Proposed In Vitro Diagnostic Devices Regulations (IVDR). http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_11663_2016_INIT&from=EN. Published August 2016. Accessed November 28, 2016.

5. Health Canada. Non-corrective contact lenses and labelling of class II medical devices, and the release of related final guidance documents and application forms. http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/mdrl_notice_fin_avis_rim-eng.php. Published July 2015. Accessed November 28, 2016.

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