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, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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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.

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  • Last Modified: Tuesday 25 June 2019, 10:20:49.
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