New York Professional Events List


Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)


Date
Nov 04, 2021 - 09:00 AM - Nov 05, 09:00 AM
Organizer
GlobalCompliancePanel
Location
Hilton Zurich AirportHohenbühlstrasse 10, 8152 Opfikon, Switzerland,

Switzerland,
Switzerland,
US,
ZIP: Switzerland
Phone: 1 929 900 1853

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...

Why should you attend:

  • Learn and understand the entire Registration and Approval Process
  • Identify and understand the changes to Medical Device Registration Process in select countries
  • Streamline the medical device registration process so that you can obtain approval for your product in the most cost-effective and timely manner
  • Learn how to access new markets and obtain medical device approval in all the countries listed
  • Complete your registration in order to obtain medical device approval as efficiently as possible while realizing that some markets/countries will be more challenging
  • Navigate the regulatory system, achieve product registration, and access the medical market
  • In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions.
  • Participants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions

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 various classes of medical devices?
  • What are other requirements that are necessary for approval in addition to the device application?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?

Who Will Benefit:

This seminar will provide an overview and in-depth snapshot of the medical device registration and approval process for Asia Pacific and with the corresponding regulatory authorities. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the medical device registration process, including:

  • Clinical Research Associates
  • Clinical Project Managers
  • Regulatory Affairs Professionals
  • Clinical Investigators and Clinical Research
  • Regulatory Affairs Management
  • Regulatory Affairs Specialists
  • Regulatory Project Leads/SME's
  • Auditors
  • Compliance Specialists
  • Clinical Affairs
  • Quality Assurance
  • Consultants
  • Distributors
===
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
- For event ticket, contact +1 929 900 1853
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
 
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Agenda


Day 1 Schedule


Lecture 1: Medical Device Registration and Approval Process
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?

Lecture 2: Exercise and Recap of Day 1

Interactive Discussions
Review of Regulatory Documents

Day 2 Schedule


Lecture 1: Medical Device Registration and Approval Process
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

Lecture 2: Exercise and Recap of Day 2

Interactive Discussions
Review of Regulatory Documents

Lecture 3: Debrief/Adjourn

Recap of topics and key discussion points and take away message
FAQs and latest trends
 

 

Event Categories
BUSINESS & MANAGEMENT CONFERENCES
,
Technology
Keywords: fun, access , business , class , Clinical , design , Fun , industry , learn, Management




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