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 Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400




The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Thursday 18 July 2024, 17:26:10.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA


Main Menu English