Frequently Asked Questions (FAQs) on Drug-Medical Device Combination Products
VARIATION ON ANCILLARY COMPONENT
1. Is it a requirement to submit application for endorsement letter when a change occurs to a particular ancillary component?
Yes. This is in line with the requirements stated in Section 6.2 : Changes/Variation To Particulars Of A Registered Medical Device-Drug Combination Product, Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products.
2. Variation procedure for a registered combination product.
3. What is the validity period of the endorsement letter issued for variation of a particular ancillary component ?
