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34594 Conferences

Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

Added by globalcompliancepanel on 2017-08-08

Conference Dates:

Start Date Start Date: 2017-10-16
Last Date Last Day: 2017-10-17
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2017-10-13

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email:
Address Address: Mandarin Orchard Singapore, Singapore, Singapore, Singapore
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Course "Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


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?

Who Will Benefit:

This seminar will provide an overview and in-depth snapshot of the medical device registration and approval process for Japan. 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
Compliance Specialists
Clinical Affairs
Quality Assurance

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

Read More: trol/globalseminars/~product_id=900988SE MINAR?worldconferencecalendar-October-20 17-SEO
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