The “Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada” training has been added to ResearchAndMarkets.com’s offering.
In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.
This 2-day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.
After completion of this two-day interactive course on IVD, the attendee will be able to:
- Understand why IVD is regulated differently.
- An overview of IVD Regulations – U.S. FDA., Europe (MDD), Canada.
- Develop Regulatory Strategies and determine Regulatory Pathways.
- Inclusion and exclusion of data and information for different submission.
- Format and Content of premarket submissions.
- Product Label and Labeling for IVDs.
- Working and interacting with the reviewers and regulators.
Tips and Suggestions to secure rapid regulatory approvals.
Key Topics Covered:
Day 01 (11:00 AM – 6:00 PM EDT)
- Evolving technologies and challenges of In-vitro Diagnostics (IVD) products
- Why the regulators need separate regulations even IVD is considered a device?
- Know the process and players at OIR (aka OIVD) of CDRH and Health Canada
- Overview of US-FDA Regulations for IVDs
- Determination of classification & Identification of Predicate Device(s)
- Development of Regulatory Strategies and Pathways for IVDs
- Special consideration of IVD labeling requirements
- Determine the type of the required pre-market submission for your IVD
- Format and Content of 510(k), Pre-IDE, IDE and PMA
- What is a Clinical Laboratory Improvement Amendment (CLIA) of 1988?
- Preparation and submission for CLIA Waiver Application
Day 02 (11:00 AM – 6:00 PM EDT)
- Overview of European IVD Regulations
- Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents
- Special consideration to Classification Rules for IVDs
- Conformity Assessment for CE Marking
- Special Labeling and electronic Labeling Requirements for IVDs
- Preparation of Technical File or Design Dossier
- Overview of Canadian Medical Device Regulations (CMDR) for IVDs
- Understanding similarities and differences between U.S. and Europe regulations
- Format and Content of Canadian Medical Device License (MDL) Application
- Inclusion of the required data and information for MDL application
- Conclusion & Summary of the course
For more information about this training visit https://www.researchandmarkets.com/r/ra5i1f
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