Step 2 of 4 : Submission for New Combination Products 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
|