Successful Product Registration in the U.S.
Before successfully registering a product in the U.S., you must meet numerous requirements. This includes ensuring that your quality management system complies with the requirements of the Quality System Regulation (21 CFR Part 820) and other regulatory requirements.
In addition to registering with the FDA and appointing a U.S. agent, you must also select the correct approval process for your product.
What sets our seminar apart?
In this interactive seminar, you will not only learn about the various requirements, but we will also use your products as examples to show you how to navigate the approval process.
Numerous illustrative examples and practical tips will help you successfully establish a foothold in the U.S. market with your products.
- Content
- Regulatory and Legal Requirements
- Organization of the FDA
- Overview of the Regulatory Framework
- Requirements of the Food and Drug Administration
- Registration and Listing
- U.S. Agent
- Access to the U.S. Market
- Product Classification
- PMA – Premarket Approval Application
- 510(k) – Premarket Notification
- Labeling / UDI
- Determining an Appropriate Approval Procedure
- Determining a Product Code
- Types of Approval Based on Product Code
- Quality Management Requirements: U.S. 21 CFR 820
- Your Benefits
- You will learn about the various requirements for product approval in the U.S.
- You will walk through the approval process for your specific product during the seminar.
- You will understand the structure of the FDA and know where to submit each application or registration.
- You will receive practical solutions tailored to your business.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Quality management professionals
- Developers and manufacturers of medical devices
- Project managers
- Manufacturers and exporters of medical devices
- Auditors
