- Guidance: Product Classification Application
- Application Form: Product Classification Application Form *
- MDDCI Table III: Reference for Medical Device - Drug - Cosmetic Interphase (MDDCI) products
- For submission or any inquiries, kindly email to firstname.lastname@example.org
- Officer Incharge:
- Pn Nur Athirah - +603 8230 0385
- En Mohd Naquib - +603 - 8230 0209
- Pn Nashirah: +603 8230 0343
*Note: Product Classification is not intended to determine the Risk and Classification of the medical devices.
- To determine whether a product is Medical Device or non-Medical 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
- Medical Device is based on function by physical means eg; mechanical action, creation of a physical barrier or replacement or support of organ or body function,
- Drug is based on pharmacological, immunological or metabolic action in/on the body.
- Active ingredient, indication and pharmaceutical dosage form (those are the main criteria for classification of the drugs), kindly refer to MDDCI Table III above.
- Classification of the product/combination product or similar product/similar combination product in the reference countries. The reference countries are US, EU, Canada, Australia and Japan.
- The primary mode of action/the principal mechanism of action may be deduced from the scientific data and the manufacturer’s labelling and claims.
- The claims made for a product, in accordance with its mode of action may represent an important factor for its qualification as a medical device.
- Circular Letter of the Medical Device Authority No. 5 Year 2016: The Medical Device Authority Meeting No. 3/2016 has decided to set the policy for imposition of charges or fees for product classification. The product classification will be charged RM300.00 per application effective on 1st December 2016.
- All fees shall be paid through bank draft. CASH WILL NOT BE accepted. We will not be responsible for the cash sent or brought to MDA;
- The bank draft must be made payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN" and sent to MDA office;
Information Needed (must be written at the back of the bank draft but not in the table section):
Title: Product Classification
i. Applicant Company’s Name:
ii. Product Name:
2. Complete submission for product classification application upon clear payment will be processed within 14 -21 working days. However, the time frame may take longer if the product needs to be further discussed.