The classification criteria below can assist in the classification of products in determining the responsible agency to regulate the device.
- The primary intended purpose of the product.
- The primary mode of action/the principal mechanism of action by which the claimed effect or purpose of the product is achieved.
- Active ingredient, indication, and pharmaceutical dosage form (these are the main criteria for the classification of the drugs)
- 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.