Global Medical Device Regulations Seminar

Course Description:

At this workshop, Dr. David Lim will walk you through to get familiar with the medical device regulations in the following twelve (12) countries.United States, EU, Canada,Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan.

This workshop is intended to provide guidance on medical device classification and registration requirements in these countries.

During this workshop (1st day), medical device regulations of twelve countries will be discussed.

On the second day, we will discuss ISO 13485, ISO 14155, ISO 14971, GHTF documents, and MEDDEV guidance documents, etc. for quality and adverse event reporting including group discussions facilitating interpretation, understanding, and implementation of medical device regulations.