An Overview:

Introducing a new and innovative medical device to the market has the potential to significantly enhance the health and well-being of millions. However, before your device can make its mark, it must successfully navigate the intricate regulatory approval processes in the European Union (EU), the U.S., and other major jurisdictions worldwide. For first-time applicants, this journey might appear daunting.

But fear not—the process is more manageable than it seems. Here is an 8-step roadmap to guide you through the regulatory review and approval process for medical devices in most major markets.

8 Important Steps to Achieving Medical Device Approval

1. Define the Product

2. Identify Relevant Regulatory Requirements

3. Establish a Test Plan

4. Assemble Representative Samples and Accessories for Testing

5. Prepare the Required Documentation

6. Submit Device for Testing

7. Obtain Product Certifications

8. Obtain Regulatory Approval

 

Conclusion

The entire approval process can take several months to over a year. Following this roadmap helps ensure your device meets regulatory requirements, minimizing surprises and delays.