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.

• Guideline on How to Apply for Product Classification
• Submission Guide for New Application of Product Classification Application
• Product Classification Application Form (Handwritten Forms are not accepted) 
• Reference Documents upon the classification of products:

1. Medical Device-Drug-Cosmetic Interphase (MDDCI) Table I
2. Classification of Rehabilitation, Physiotherapy and Speech Therapy Device 
3. Harmonised Borderline Products in ASEAN 
4. List of Non-Medical Device Products 2022-2023 

• For SUBMISSION or INQUIRIES, please email to classification@mda.gov.my
  Officer In-charge:

1. Nur Athirah - +603 8230 0385 
2. Che Rosmani - +603 8230 0371
3. Nur Syafura - +603 8230 0352
4. Aidahwaty - +603 8230 0341

 

 

 Updated: 30th July 2024