Step 2 of 4 : Submission for New Product Registration

The following dossier shall be submitted by the applicant for the purpose of registering combination product:


Dossier Requirement for Drug Component

Dossier Requirement for Medical Device Component

Drug-Medical Device Combination Product

Refer to DRGD, Appendix 2: Requirements for Product Registration 


For product registration :






Refer to Appendix 2: Ancillary Medical Device Dossier Requirement for Drug-Medical Device Combination Product

Medical Device-Drug Combination Product

Refer to Appendix 3: Ancillary Drug Dossier Requirement for Medical Device-Drug Combination Product

Refer to MDA/GD-04: Common Submission Dossier Template First Edition March 2014


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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