Japan's Medical Device Approval Process

John Riggi

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This webinar will discuss the basics of product registration in Japan such as Registration Timelines, documentation requirements and governmental processes.

Why Should You Attend:

Relevance of this webinar is to provide a clear foundation for the firm’s education on registration in Japan.

Japan’s registration requirements are extensive, specific and need to be fully understood prior to attempting registration in that country.

Mistakes in registration dossiers or noncompliance to the registration processes result in significant registration timeline delays or potential resubmission of product dossiers.

All medical device companies wishing to do business in these countries will need to submit product dossiers for review prior to sale of products in those countries. This webinar will teach you what is required as well as governmental interactions and processes.

Areas Covered in the Webinar:

  • Device registration requirements
  • Dossier content requirements
  • Timeline to registration
  • Project Timeline
  • In-country registration assistance
  • 3rd party agents vs. distributors
  • Costs
  • Re-registration

Who Will Benefit:

  • Senior Quality Assurance staff
  • Senior Regulatory Affairs staff
  • Regulatory auditors
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: John Riggi, President and CEO, Lake Ontario MED DEV Consultants

With over 40 years of experience in the medical device industry, Mr. Riggi’s success spans the following industry sectors:

  • Ophthalmics
  • Orthopedics
  • High Volume Device Production
  • Cardiac Rhythm Management
  • Neurostimulation
  • Infusion Technologies
  • Medical and Dental Radiation Devices

Mr. Riggi brings this extensive experience to the client in the areas of:

  • Global Quality Assurance/Regulatory Operations
  • Global quality system development, implementation and assessment
  • Client assistance during third party/regulator audits, inspections and assessments
  • Medical Device Design Control
  • Radiation safety
  • Regulatory Compliance and Product Submissions
  • Client assistance in registration dossier preparation
  • Training on quality system regulations (US, EU, Canada, Brazil, China, Japan, Korea and Russia), MDSAP and EUMDR
  • Corporate Compliance Assessment Programs
  • ISO/CE Certification Processes
  • Vendor Quality
  • Enterprise Management System Leadership
  • Regulatory/Notified Body Relationships
  • Global medical device product registrations (US, EU, Canada, Brazil, China, Japan, Korea, Russia and numerous other jurisdictions in Latin America and Asia)

Whether on the manufacturing floor or in front of large conference audiences, Mr. Riggi's open and relaxed communication talents ensure maximum value for the client.

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