About the Author: Mohamed Bashim
Updating the Medical Device Marketing Authorization (MDMA) can often feel daunting. Even minor updates, like changes in the label, require a specific notification process. The Saudi Food and Drug Authority (SFDA) recently published a guideline about the MDMA update and implementation of the changes in the registration information. This process needs to be performed by the manufacturers’ authorised representatives. Let’s break down the two MDMA update types: the significant and non-significant changes.
Table of contents
Significant Changes
As the name suggests, significant changes are major adjustments that could impact your medical device’s safety, performance, or intended use. Examples include:
- Altering the intended use or instructions for use (IFU)
- Changing the sterilisation method
- Modifications in your manufacturing process or subcontractor
- Adjustments in your Quality Management System (QMS) or software
These changes must be reported to the SFDA using the “Medical Device Change Form” template within 10 days and require prior approval.
Non-Significant Changes
Conversely, non-significant changes are the minor updates that don’t significantly affect device performance or safety. These can include:
- Simple updates to artwork or packaging
- Changes involving non-critical suppliers
- Minor adjustments that do not impact functionality
For such changes, the applicant must notify the SFDA within 30 days using the “Medical Device Change Form.” However, the authority may request the applicant to submit an MDMA update.
The applicant must briefly describe the change in the notification form, including the device name, MDMA number, model number, and national listing number. The SFDA must receive this notification within 90 days of the change; note that the implementation does not require prior approval.
In Conclusion
The planning of the MDMA update helps you manage your supply and resources more effectively. By distinguishing between significant and non-significant changes, you can save time, reduce stress, and maintain compliance without feeling overwhelmed.
Regulatory Support
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