Re: European FDA Equivalent

P Martin marti...@appliedbiosystems.com To: emc-p...@majordomo.ieee.org Sent: Tuesday, August 06, 2002 10:33 PM Subject: European FDA Equivalent Is there a European and/or Canadian equivalent to the FDA in the US in regards to diagnostic medical equipment? If so, what are the organizations

Re: European FDA Equivalent

In Canada, the analagous organization is Health Canada. Similar rules and responsibilities to FDA. The European system is somewhat different. All medical devices being marketed or placed into service in Europe must comply with the European Medical Device Directive (MDD) and carry a CE