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Product Classification

*Note: Product Classification is not intended to determine the Risk and Classification of the medical devices.

Objective:

  • To determine whether a product is Medical Device or non-Medical Device

Classification Criteria:

  • 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
    1. 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,
    2. 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 I 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.
  1. 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.

Payment

  • 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 or online transfer. CASH WILL NOT BE accepted. We will not be responsible for the cash sent or brought to MDA ;
  1. 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. ONLINE TRANSFER method can be made by sending an official email to classification@mdb.gov.my with complete submission of the application form.

    3. Time frame for processing application form is within 14 to 21 working days after the date of payment is cleared. However, the time frame may take longer if the product needs to be further discussed.

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 27 July 2021.
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