Medical Device Registration Requirements in Saudi Arabia and MEA
Instructor:
John Riggi
Product ID: 706291
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 these three important Latin American countries.
While Saudi Arabia has long been pre-eminent in Medical Device regulation and registration, other countries in MEA have followed Suit. 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.
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