Product Classification Guideline (Medical Device-Drug-Cosmetic Interphase Products)

MEDICAL DEVICE - DRUG - COSMETIC INTERPHASE PRODUCTS

Medical Device-Drug-Cosmetic Interphase (MDDCI) Products are those products that are not clearly defined as a medical device or drug/cosmetic in accordance to the Medical Device Act 737, Control of Drugs and Cosmetics Regulations 1984 and Sale of Drugs Act 1952.

Registration of drug products/ notification of cosmetics that has been classified must follow the requirements that have been set forth as follows:

Drugs & Cosmetics – The registration/ notification regulated by the NPRA is in accordance with the requirements set forth in the Poisons Act 1952 and its Regulations, Sales of Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984;
Medical Device – The registration regulated by Medical Device Authority is in accordance with the requirements set forth in the Medical Devices Act 2012 (Act 737).

Combination products 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 Interphase Product and Combination Product (Device-Drug or Drug-Device), it will be regulated according to the classification that has been made and by the relevant agencies.

Please refer ;

(i) Direktif Kuatkuasa Pemakaian Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products

(ii) Guideline For Registration Of Drug-Medical Device and Medical Device-Drug Combination Products

(iii) Pekeliling Lanjutan Tarikh Pelaksanaan Pemakaian Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products

CLASSIFICATION CRITERIA

(a) The primary intended purpose of the product;

(b) 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; but

Medical device does not achieve its primary mode of action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its intended function by such means.;

(c) Active ingredient, indication and pharmaceutical dosage form (these are the main criteria for classification of the drugs);

(d) Classification of the products in reference countries.

For classification of MDDCI products and combination products as decided by the committee, please refer to APPENDIX 2, Table I : SUMMARY OF MEDICAL DEVICE-DRUG-COSMETIC INTERPHASE (MDDCI) PRODUCT CLASSIFICATION DECISION (click here)