Product Classification Application:

 

To determine whether the product is classified as a medical device or non-medical device product by the definition of medical device under Act 737.

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

 

A. Application form: Product Classification Application Form 

B. Instant Guide for Product Classification Application:

  1. Product Classification Flowchart 
  2. Guideline on How to Apply For Product Classification 
  3. E-Submission Guide for New Application 
  4. E-Submission Guide for Renewal Application (Coming soon)

 

C. Reference Documents on the Classification of Products:

  1. Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products 
  2. Harmonised Borderline Products in ASEAN 
  3. Classification of Rehabilitation, Physiotherapy and Speech Therapy Device  
  4. Classification Guide on Human Cell/Tissue Based Products 
  5. List of Non-Medical Device Products 2022 – 2023 
  6. Product Classification Reference Letter for Year 2023-2024 

 

D. Any manual submission or inquiries, please email to: classification@mda.gov.my

 

E. Contact number of the relevant officers:

  1. Nur Athirah: +603 8230 0385
  2. Norfazila: +603 8230 0399
  3. Aidahwaty: +603 8230 0341

 

 

 

 

 

 

 Last Updated: 26th of March 2025