FAQ drug-medical device combination product variation
- General
- Endorsement Letter
- Variation On Ancillary Component
- Renewal (Re-Registration) Of Product Registration
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.
Kindly refer to 6.0 Changes/ Variation To Particulars Of A Registered Combination Product, Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products available at here.
3. What is the validity period of the endorsement letter issued for variation of a particular ancillary component ?
The current policy stipulates the validity period of endorsement letter shall be in line with the validity period of combination product registration. However, this matter will be further scrutinized in variation guideline which is currently under development.