PRODUCT CLASSIFICATION

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.

NEW INFORMATION & ANNOUNCEMENT:

2026:

1. Announcement Subject: Update On Product Classification Application System And Implementation Of Validity Period For Product Classification Letter blink_blink_1.jpeg

2. Announcement: Transition from Google Form to Product Classification Application  System  blink_blink_1.jpeg

3.  Guideline for New Product Classification Application System blink_blink_1.jpeg

2025:

  1. Implementation of Validity Period for Product Classification Letter blink_blink_1.jpeg
  2. Announcement Transition to Fully Online Product Classification Application Process   (Refer to the updated announcement as per above)
  3. Announcement on Implementation of Validity Period for Product Classification Letter (Refer to the updated announcement as per above)

 

A. Application form:
 

  1. Product Classification Application Form 'Click Here' 
  2. Google Form (will be discontinued on 1 August 2026)

 

B. Overview of Product Classification Process

  1.  New Application of Product Classification  
  2.  Renewal Application of Product Classification 

 

C. Guide for Product Classification Application:

  1. New Application of Product Classification Flowchart   
  2.  Renewal Application of Product Classification Flowchart  
  3.  Guideline on How to Apply for Product Classification 
  4. Submission Guide for New Application of Product Classification Application
  5.  Submission Guide for Renewal Application of Product Classification Application

 

D. 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
  6. Product Classification Reference Letter for Year 2023-2024 

 

E. Any inquiries, please email to: classification@mda.gov.my

 

F. Contact number of the relevant officers:

1. Nurul Hidayah : +603 8230 0354 
2. Maryam Nazeera : +603 8230 0355
3. Nur Athirah : +603 8230 0385
4. Anish Ameera : +603 8230 0270
5. Kaunter Pendaftaran: +603 8230 0376

Last Updated: 30th of September 2026

 Prepared by: Pre-Market Control Division 

Uploaded by: Corporate Communication Division