Product Classification

*Note:

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.
  • 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. CASH WILL NOT BE accepted. We will not be responsible for the cash sent or brought to MDA;
  1. The bank draft must be made payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN" and sent to MDA office;
  2. Information on reference number and Phone No. of the applicant must be written at the back of the bank draft but not in the table section;
  3. 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.

 

FLOWCHART FOR PRODUCT CLASSIFICATION APPLICATION 2019

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