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DESCRIPTION Overview: -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 -The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. -In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy. -And Much More...
Date :
Place : India, Mumbai
Contact Person:Paula Edwards
Description:
DESCRIPTION Overview: -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 -The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. -In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy. -And Much More...DESCRIPTION Overview: -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 -The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. -In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy. -And Much More... will be held in Mumbai,India on date 2017-11-10
Deadline for abstracts/proposals : 6th November 2017
Organized By :New York Events List
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 :Mumbai, MH 400059, India
Check the event website for more details.
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