Frequently Asked Questions (FAQs) on Drug-Medical Device 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?
