Japan's Medical Device Approval Process
Instructor:
John Riggi
Product ID: 706293
Training Level: Basic
- Duration: 60 Min
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
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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
