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COMBINATION PRODUCT

Guideline: Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products

 

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.

CARTA ALIR

Application for an Endorsement Letter for Ancillary Medical Device Components

 

Checklist for submission:

 

Application for a Change/Variation of Ancillary Components for Combination Products

 

Checklist for submission:

 

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: combination.product@mda.gov.my

For further information, refer Guideline For Registration of Drug Medical Device and Medical Device Drug Combination Products 4th Edition and Frequently Asked Questions (FAQs) 

 

 

 

 

 

 

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 30 November 2021.
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