Medical Device Change Registration Decision Tool

ß Launch

Purpose

Example inputs: “new distributor appointed,” “change in product owner,” “no changes in IFU,” “Relinquishing Company ceases busine

Outout

✅ Decision Logic:

The tool would match the input against a keyword set and return answers like:

Change of Registrant Required: ✅ Yes
Reason: Appointment of new registrant by Product Owner.
Preconditions:
- The device is listed on SMDR.
- No pending applications like change notifications or cancellations.
Documents Needed:
- Letter of Authorisation (from Product Owner) – GN-15 template.
- Letter of Request (Annex 1).
- Relinquishing Company Declaration Form (Annex 2).
Submit via: SHARE

❌ Change Not Required:

Change of Registrant Required: ❌ No
Reason: (e.g., "The registrant remains the same, only distributor changes.")
Next Step: Consider submitting a Change Notification if product-related documents (e.g., IFU, labels) change.