Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017
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.
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?
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
• Auditors
• Compliance Specialists
• Clinical Affairs
• Quality Assurance
• Consultants
• Distributors
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
•
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?
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
• Auditors
• Compliance Specialists
• Clinical Affairs
• Quality Assurance
• Consultants
• Distributors
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
•
Sponsored Conferences
