The classification criteria below can assist in the classification of products in determining the responsible agency to regulate the device.

  1. The primary intended purpose of the product.
  2. The primary mode of action/the principal mechanism of action by which the claimed effect or purpose of the product is achieved.
  3. Active ingredient, indication, and pharmaceutical dosage form (these are the main criteria for the classification of the drugs)
  4. Classification of the products in reference countries.

The full list of products of MDDCI for guidance classification decision, including the responsible agency is listed in the updated schedule.


Medical Device-Drug-cosmetic Interphase (MDDCI) Product Revision