Frequently Asked Questions (FAQs) on Drug-Medical Device Combination Products


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 ?

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
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  • Last Modified: Jumaat 15 Oktober 2021, 15:58:04.
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