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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