COMBINATION PRODUCT
Guideline: Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products
For submission or any enquiries, kindly contact Registration Unit:
- Email:
- Phone Number: Registration Unit +603 8230 0376 or Pn. Aidahwaty bt Ariffin +603 8230 0341
Definition of Combination Product
The term combination product includes:
- 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;
- Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products.
For examples of classification of Medical Device-Drug-Cosmetic Interphase (MDDCI) products and combination products as decided by the MDDCI committee, please refer to Table I: Medical Device-Drug-Cosmetic Interphase (MDDCI) Product Classification Decision. It shall be used as guidance for classification only.
Registration Process of Combination Products
The primary agency for registration of combination product is based on the primary mode of action/the principal mechanism of action by which the claimed effect or purpose of the product is achieved:
- Drug is based on pharmacological, immunological or metabolic action in/on the body; shall be regulated by NPRA;
- Medical device does not achieve its primary mode of action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; shall be regulated by MDA.
Application for an Endorsement Letter for Ancillary Medical Device Components
Checklist for submission:
- An official / cover letter
- Application form for endorsement letter of ancillary component for the registration of combination product – Appendix 3
- Checklist for submission of ancillary medical device component – Appendix 3
- Ancillary medical device dossier - Appendix 1 of Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Product, Table 4
Application for a Change/Variation of Ancillary Components for Combination Products
Checklist for submission:
- An official / cover letter
- Application form for change/variation of ancillary components for combination products – Appendix 4
- Summary Table of Changes
The form and supporting documents can be sent manually (hardcopy document with PDF electronic copy on a CD or Thumb Drive) to:
Chief Executive,
Medical Device Authority,
Level 6, Prima 9, Prima Avenue II, Blok 3547, Persiaran APEC,
63000 Cyberjaya, Selangor.
Email:
For further information, refer Guideline For Registration of Drug Medical Device and Medical Device Drug Combination Products 5th Edition and Frequently Asked Questions (FAQs)
Updated: 11 January 2023
