FAQ drug-medical device combination product general renewal
- General
- Endorsement Letter
- Variation On Ancillary Component
- Renewal (Re-Registration) Of Product Registration
- Variation on Medical Device-Drug Combination Products
RENEWAL (RE-REGISTRATION) OF PRODUCT REGISTRATION
1. Is the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products applicable to renewal of combination products registration?
Yes, the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products is applicable during renewal application if the combination product registration ends on/ after 1st July 2019. Hence, the endorsement letter of the ancillary component will be required during renewal of these products.
2. Where should I attach the endorsement letter of the medical device ancillary component during renewal application for drug-medical device combination product?
Endorsement letter of the medical device ancillary component is required to be uploaded at Part I, E14. Other Supporting Documents under the Quest 3+ system during renewal application.