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?

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

Image   Image   Image   Image  

DISCLAIMER

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: Wednesday 27 March 2024, 22:44:22.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Search

Main Menu English