Definition of Combination Product:

The term combination product includes:

  1. A product comprised of two or more regulated components, i.e., drug/ device, biological/ device, or drug/ device/ biological, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; OR
  2. Two or more separate products packaged together (co-packaged) in a single package or as a unit and comprised of drug and device products, device and biological products.

1. Related Guideline Document

2. Overview of Combination Product Registration Framework

3. Example of Combination Product as Decided by MDDCI Committee

4. Process Flow for Endorsement Letter for Ancillary Medical Device Component Application

5. Application Form for Endorsement Letter for Ancillary Medical Device Component Application

6. Overview of Post-Approval Changes of a Registered Combination Product (Changes to Ancillary Medical Device Component) Framework

7. Process Flow for Approval Letter for Post-Approval Changes to Ancillary Medical Device Component Application

8. Application Form for Approval Letter and Summary Table of Changes for Post-Approval Changes to Ancillary Medical Device Component Application

9. Information on Fee Structure for Application of Endorsement Letter and Approval Letter for Post-Approval Changes of Ancillary Medical Device Component

10. Combination Product Unit Statistic (Year 2023)

11. Frequently Ask Questions (FAQs)

12. For any inquiries, kindly contact us for further assistance:

a. Combination Product Unit email address:

b. Combination Product Unit telephone number:

 i. Aidahwaty Ariffin @ Aidahwaty M.Olaybal, A.M.N. (Director of Pre-Market Division)

      • Office Number: +603 8230 0341

ii. Azizah Munirah Ab Keram @ Ab Karem (Assistant Director of Combination Product Unit, Pre-Market Division)

      • Office number: +603 8230 0237

 

Combination Product Unit,

Pre-Market Control Division, MDA

Information is updated on 18th Oct 2024