DESCRIPTION Course Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations) has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. -Classification systems differ from that of the United States or European Union in select countries -Medical devices are classified depending on their risk level -Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements -Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia

Date : 2nd November 2017 to 3rd November 2017

Place : Switzerland, zurich

Website :https://www.eventbrite.com/e/medical-device-registration-and-approval-process-for-the-pacific-rim-including-india-japan-china-tickets-32333062059?aff=NDT

Contact Person:Paula Edwards

Description:

DESCRIPTION Course "Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. -Classification systems differ from that of the United States or European Union in select countries -Medical devices are classified depending on their risk level -Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements -Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia

DESCRIPTION Course Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations) has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. -Classification systems differ from that of the United States or European Union in select countries -Medical devices are classified depending on their risk level -Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements -Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia will be held in zurich,Switzerland on date 2017-11-03

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Deadline for abstracts/proposals : 31st October 2017

Keynote Speakers : David R. Dills Global Regulatory Affairs & Compliance Consultant David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems

Conference Highlights :Areas Covered in the Session: -Which regulatory bodies are responsible for medical device registration in each country? -Are medical devices required to be registered before they can be sold? -What are the different regulatory classifications for medical devices? -What are the different application categories for medical device registration? -What does the registration pathway look like for each regulatory classification? -What are the document requirements for notification for the vario

Venue :Opfikon, Switzerland

Check the event website for more details.