PRODUCT CLASSIFICATION

 

Product Classification Application: 

To determine whether the product is classified as a medical device or a 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.

 

ANNOUNCEMENT:

  1. Announcement Transition to Fully Online Product Classification Application Process
  2. Announcement on Implementation Of Validity Period For Product Classification Letter

 

A. Application form: Google Form

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 
  5.  Submission Guide for Renewal 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 2022 – 2023 
  6. Product Classification Reference Letter for Year 2023-2024 

 

D. Any inquiries, please email to: [email protected]

 

E. Contact number of the relevant officers:

  1. Nur Athirah: +603 8230 0385
  2. Anish Ameera: +603 8230 270
  3. Norfazila: +603 8230 0399
  4. Nur Syafura: +603 8230 0352
  5. Aidahwaty: +603 8230 0341

 

 

 

 Last Updated: 23 July 2025

 Prepared by: Pre-Market Control Division 

Uploaded by: Corporate Communication Division