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Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)
Nov 02, 2017 - 09:00 AM - Nov 03, 06:00 PM
Link to Website
Global Compliance Panel
Hilton Zurich Airport Hohenbühlstrasse 10, 8152 Opfikon, Switzerland,
Phone: 1 929 900 1853
Day 1 Schedule
Introductions and Background
China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia and overview of the pre and post-registration and approval process
What is the classification scheme for medical devices?
What are the registration procedures?
How are devices classified?
How do regulatory requirements differ for domestic vs. foreign manufacturers?
How long does it take to register devices?
New Registration Pathways for Manufacturers
Revised medical device registration and approval requirements in select countries
Quality management systems (QMS) are streamlined
QMS inspections with Marketing Authorization Holders and Manufacturers
Key Guidelines and Resources
Will our clinical studies and testing conducted outside the countries be accepted?
Review of Regulatory Documents
Day 2 Schedule
Medical Device Registration and Approval Process and Recap from Day 1
China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia and overview of the pre-registration and post-registration and approval process
Documentation required for review and approval
Registration and country codes and other requirements
In-Country Representative/Marketing Authorization Holders/Authorized Representatives
QMS and other requirements
Documentation and Additional Materials for Registration and Approval
Consultation sessions with Regulatory Authorities, how to maximize foreign clinical data, and how to expedite product registration
Trends and lessons learned with recent and current registrations
New medical device regulations and approval requirements are released on a regular basis sometimes and companies must keep track and current
Responding to inquiries and questions from the Regulatory Authorities/Agencies
Regulatory inspection process
Review of Regulatory Documents
FAQs and latest trends
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