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.
Drug-medical device/ medical device-drug combination products are regulated according to the classification whether as drug or medical device.
- Combination products regulated as medical device by Medical Device Authority is in accordance with the requirements set forth in the Medical Device Act 2012 (Act 737) and its subsidiary legislations, and any other relevant documents published by MDA.
- Combination products regulated as drug by Drug Control Authority is in accordance with the requirements set forth in the Control of Drugs and Cosmetics Regulations 1984 which is promulgated under Sale of Drug Act 1952 and any other relevant documents published by NPRA.
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
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 III: Medical Device-Drug-Cosmetic Interphase (MDDCI) Product Classification Decision. It shall be used as guidance for classification only.
For further information, refer Guideline For Registration of Drug Medical Device and Medical Device Drug Combination Products Second Edition , Frequently Asked Questions (FAQs) and Circular Letter of the Medical Device Authority No.3 Year 2017 (Revision 1)