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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
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Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices - Singapore  

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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

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Training Course Syllabus:


Overview:
Japan´s classification system differs from that of the United States or European Union
Medical devices are classified to Class I, II, III, or IV depending on their risk level
Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements
Strict new package insert requirements
Change to MAH Licensing rules
A new MAH License category for In Vitro Diagnostic (IVD) devices
A new registration system for manufacturers
A new QMS conformity assessment system
New formats for pre-market certification and pre-market approval applications
Expanded scope of third party certifications
Rules for software as a medical device
Rules for transferring pre-market certifications
And Much More...
Why should you attend:

Understand the entire Registration and Approval Process in Japan
Identify and understand the Major Changes to Medical Device Registration Process in Japan
Streamline the medical device registration process so that you can obtain approval for your product in the most cost-effective and timely manner
Participants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions
Review and discuss pain points, challenges and solutions
Areas Covered in the Session:

Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
In Japan, 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?

Agenda:
Day 1 Schedule

Lecture 1: Medical Device Registration and Approval Process

Introductions and Background
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 Japan
Some Class III medical devices can undergo third party certification
Medical software programs are independently regulated
Manufacturers are required to be registered rather than be licensed
Quality management systems (QMS) are streamlined
QMS inspection is conducted on the Marketing Authorization Holder and is conducted per product family, not on individual products
Changes to Marketing Authorization Holder System
Key Guidelines and Resources
Will our clinical studies and testing conducted outside Japan 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
Documentation required for review and approval
Registration and JMDN Codes
In-Country Representative/DMAH
QMS and other requirements
Documentation and Additional Materials for Registration and Approval
Consultation sessions with Regulatory Authority, 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
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

Speaker:
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.

Seminar Summary:

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