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

  • 1695.00 Dollar US$
  • Published date: August 23, 2017
    • Singapore, Mandarin Orchard Singapore, Singapore





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?




Location: Singapore Date: October 16th & 17th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Mandarin Orchard Singapore 333 Orchard Road, Singapore 238867
Tel: (65) 6235 7788
Price:

Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until August 31, Early Bird Price: $1,695.00 From September 01 to October 14, Regular Price: $1,895.00
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As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
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