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

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

 

  • Registration - Early bird( 5 or more participants 10% discount )

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    INR 14000
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  • Regsitration - Regular

    Sale Date Ended

    INR 16000
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About The Event

Course "Medical Device Registration and Approval Process for the Pacic 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.

 

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. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness

 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

 

Agenda:

 

Day One


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?

Exercise and Recap of Day 1


  • Interactive Discussions
  • Review of Regulatory Documents

Day Two


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

Exercise and Recap of Day 2


  • Interactive Discussions
  • Review of Regulatory Documents

Debrief/Adjourn


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

Venue Map