Understanding global medical device regulations and requirement and adequate implementation of applicable medical device regulations can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

1. Complianzworld.com
Seminar Topic
“Global Medical Device Regulations:
US, EU, Canada, Argentina, Australia, Brazil, India, J
apan, Mexico, Russia, South Korea, Taiwan: One
and a Half-day In-person Seminar”
www.Complianzworld.com

2. Course Description:
Understanding global medical device regulations and
requirement and adequate implementation of
applicable medical device regulations can significantly
expedite the regulatory processes, bringing
innovative medical products to the global market
faster and saving enormous amount of your
unnecessary time, efforts and investment.
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.

3. Reasons to attend:
In this One and a Half-day In-person Seminar the trainer will walk you through to
get familiar with the medical device regulations in the following twelve (12)
countries.
• US
• 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.

4. The Following areas will be
discussed during the 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

5. Target Audience:
This seminar will be valuable for anyone in the European
Commission (EC) and FDA-regulated industry, including, but
not limited to, medical devices, active implantable
medical devices, in vitro diagnostic medical devices or
combination products. This seminar will be particularly
useful for those involved in research and product
development, handling data and documents for regulatory
submission for CE-marking
purposes, conducting/monitoring/coordinating clinical
investigation, and/or performing risk management and
post-market vigilance/surveillance. This workshop is a
must for those who are directly or indirectly involved in
drafting and handling applications for CE marking
purposes.

6. The Following personnel will benefit
from the course:
• Regulatory affairs (associates, specialists, managers, and directors)
• Quality assurance, quality control, and quality systems
(associates, specialists, engineers, managers, directors and VPs)
• Research and development
(associates, scientists, managers, directors and VPs)
• Product and development (associates, scientists, managers, directors
and VPs)
• Contract research organization
(associates, scientists, managers, directors and VPs)
• Site managers, and consultants
• Senior and executive management (VPs, SVPs, Presidents and CEOs)
• Contractors and subcontractors
• Anyone interested!