FAQ drug-medical device combination product variation
- General
- Endorsement Letter
- Variation On Ancillary Component
- Renewal (Re-Registration) Of Product Registration
VARIATION
1. Is it a requirement to submit application for endorsement letter when a change occurs to a particular ancillary component?
The Endorsement Letter/ Acknowledgement Receipt of the ancillary medical device component shall be uploaded through the online Quest 3+ Variation Module under category Minor Variation Notification (MiV-N): Updating of Endorsement Letter/ Approval Letter from Medical Device Authority for Drug-Device Combination at field E14 (Other supporting documents).
For registered product containing ancillary medical device, kindly include the statement ‘“This product contains a medical device component” at field A4 (Product Description). This statement should be added at the top of the current product description.
2. How long does it take for the MiV-N to be acknowledged?
Kindly refer to the timeline in Malaysian Variation Guideline (MVG) For Pharmaceutical Products and Malaysian Variation Guideline For Biologics (MVBG).
3. How do I know whether the MiV-N had been acknowledged?
You may check the status through the online Quest 3+ Variation Module.
4. What will be the fees imposed for variation to particulars of a registered drug-medical device combination product?
Kindly refer to 1.4 Charges for amendments to particulars of a registered product, Drug Registration Guidance Document.
5. What is the difference between Endorsement Letter and Approval Letter?
Endorsement Letter will be issued by the secondary agency after satisfactory review of the ancillary component.
Approval Letter will be issued by the secondary agency after satisfactory review of the changes/ variation to particulars of a registered combination product.
6. Do I need to notify NPRA regarding the changes/variation approval for the ancillary medical device component received from MDA?
Yes. Kindly upload the approval letter through online Quest 3+ Variation Module under category Minor Variation Notification (MiV-N): Updating of Endorsement Letter/ Approval Letter from Medical Device Authority for Drug-Device Combination.
7. Can I group the variation to upload the Endorsement Letter/ Acknowledgement Receipt of the ancillary medical device component for a few registered products?
No. Submission of variation is product specific.
8. Do I need to replace the Acknowledgement Receipt with the Endorsement Letter at online Quest 3+?
Kindly upload the Endorsement Letter of the ancillary medical device component through the online Quest 3+ Variation Module under category Minor Variation Notification (MiV-N): Updating of Endorsement Letter/ Approval Letter from Medical Device Authority for Drug-Device Combination.