2020 - Global Medical Device Regulations - US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan

At this workshop, you will get familiar with medical device regulations of twelve (12) countries concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices for adequate implementation and successful registration.
The following areas will be discussed during workshop:
Medical device regulations in US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan
In EU, the following four Directives will be discussed.
DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
DIRECTIVE 2007/47/EC Amending MDD and AIMDD
ISO 13485
ISO 14155
ISO 14971
GHTF documents
MEDDEV guidance documents
Clinical investigation
Adverse event reporting