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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.
A. Application form: Product Classification Application Form
B. Instant Guide for Product Classification Application:
- Product Classification Flowchart
- Guideline on How to Apply For Product Classification
- E-Submission Guide for New Application
- E-Submission Guide for Renewal Application (Coming soon)
C. Reference Documents on the Classification of Products:
- Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products
- Harmonised Borderline Products in ASEAN
- Classification of Rehabilitation, Physiotherapy and Speech Therapy Device
- Classification Guide on Human Cell/Tissue Based Products
- List of Non-Medical Device Products 2022 – 2023
- 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:
- Nur Athirah: +603 8230 0385
- Norfazila: +603 8230 0399
- Aidahwaty: +603 8230 0341
Last Updated: 26th of March 2025