Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

Regulatory Filing Requirements and Compliance Processes for Medical Devices is organized by GlobalCompliancePanel and would be held during Oct 12 - 13, 2017 at Hilton Zurich Airport, Zurich, Switzerland. This CME Conference has been approved with a maximum of 12 CME Credits.

The target audience for this medical event for:

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

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?

Additional details will be posted as soon as they are available.