Simon Medtech Solutions
December 10th 2025
AMMPS Publishes New Notification Form for Incidents and Potential Incidents Related to In Vitro Diagnostic Reagents
Answers to your Questions
The published form is intended for reporting:
Confirmed incidents linked to the use of RUDIV
Potential incidents that could have led to harm if they had not been detected in time
Any malfunction, performance issue, or deterioration that may impact patient safety or test reliability
This initiative aligns with international best practices in vigilance and reinforces Morocco’s commitment to ensuring the safety and performance of in vitro diagnostic technologies.
The AMMPS requires its use by:
Manufacturers and their authorized representatives
Importers and distributors of IVD reagents
Healthcare institutions and diagnostic laboratories
Any professional involved in the use, supervision, or maintenance of IVD reagents
The form is now available on the AMMPS website and is required for all future reports concerning incidents or potential incidents related to RUDIV.
You may also download the form directly from our website using the link above, or contact us via WhatsApp or email should you require it to be shared with you directly.
The adoption of this standardized notification process will:
Improve the completeness and consistency of incident reports
Facilitate analysis and trend monitoring
Support faster risk mitigation and corrective actions
Strengthen regulatory compliance for all IVD stakeholders
We, Simon Medtech Solutions assist manufacturers, importers, distributors and laboratories in:
Preparing and submitting incident notifications
Establishing robust post-market surveillance procedures
Ensuring compliance with Moroccan regulatory requirements for IVD products
If you need help adapting your vigilance system or managing a notification, our team is available to support you.
