Overview of the Regulation of Medical Devices and Drugs in the European Union and the United States-Reference-Cited by-同舟云学术

Overview of the Regulation of Medical Devices and Drugs in the European Union and the United States

Published:2013-11 Issue:6 Volume:47 Page:715-722
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Masterson Fiona,Cormican Kathryn

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/10.1177/2168479013500969.pdf

Reference15 articles.

1. European Commission. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. L 169. Official Journal of the European Communities. 1993; July 12:1–43.

2. European Commission. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. L 189. Official Journal of the European Communities. 1990;July 20:17–36.

3. European Commission. Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. L 331. Official Journal of the European Communities. 1998;December 7:1–37.

4. International Organization for Standardization. DIN EN ISO 14155 2012–01. Clinical investigation of medical devices for human subjects: good clinical practice.

5. FDA. Title 21, parts 800–1299. In: Code of Federal Regulations. Washington, DC: US Department of Health and Human Services; 2002.

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