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

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

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