Japan's Medical Device Approval Process

Instructor: John Riggi
Product ID: 706293
Training Level: Basic
  • 11
  • February 2020
    Tuesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min
This webinar will discuss the basics of product registration in Japan such as Registration Timelines, documentation requirements and governmental processes.

Live Online Training
February 11, Tuesday 10:00 AM PST | 01:00 PM EST | Duration: 60 Min

$229.00
One Dial-in One Attendee
$599.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$399.00

Live + Training CD/USB

$499.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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
Instructor Profile:
John Riggi

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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