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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

 

 

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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.

Site Last Modified

  • Last Modified: Isnin 09 Disember 2024, 11:07:51.

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