Back in May, we released an in-depth white paper on the Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC), a framework introduced by IMDRF to harmonize medical device submissions worldwide.
Why does this matter?
The nIVD MA ToC provides a standardized, modular structure that helps manufacturers manage complex global regulatory requirements. It can streamline both initial registrations and re-registrations across multiple jurisdictions. However, aligning the framework with diverse and evolving regional requirements remains a challenge.
In the white paper, we explore:
- The advantages of adopting the nIVD MA ToC
- The main hurdles manufacturers face during implementation
- Practical strategies to ensure smooth submissions while maintaining compliance
Download the full white paper here: https://www.starodub.nl/whitepapers/the-challenges-of-using-nivd-ma-toc-for-medical-device-registration/
We are also curious to hear about your own experiences with the nIVD MA ToC. What opportunities or challenges have you encountered so far?
At Starodub, we specialize in guiding medical device manufacturers through this process with expertise, technology solutions, and regulatory insight.
If you are looking for guidance in setting up or implementing the nIVD MA ToC, the team at Starodub is here to help. Feel free to reach out to us directly at [email protected]
