The Medical Device Authority (MDA) Malaysia has announced the transition to a fully online Product Classification Application Process, effective 1 August 2026.
Under this initiative, all product classification applications must be submitted through the newly introduced Online Product Classification Application System, replacing the existing Google Form submission method.
This digital transformation aims to improve operational efficiency, streamline application management, and provide a more user-friendly submission experience for applicants.
Read the full announcement here:
ANNOUNCEMENT TRANSITION TO FULLY ONLINE PRODUCT CLASSIFICATION APPLICATION PROCESS
Key Highlights
Implementation Timeline
Effective 1 August 2026, all product classification applications must be submitted exclusively through the Online Product Classification Application System.
Additional information and user guidance will be provided before the implementation date.
Electronic Issuance of Classification Letters
Upon approval, the official Product Classification Letter will be issued electronically and delivered to the email address provided in the application.
Hard-copy classification letters will no longer be issued.
Online Product Classification Application System
To submit an application through the Product Classification Application System, please visit:
https://pc.mda.gov.my/?p=freesales/index.php
Product Classification Guidelines
For step-by-step instructions, please refer to the official MDA Product Classification Guidelines:
https://portal.mda.gov.my/index.php/documents/ukk/4259-product-classification-application-final-21-july-2026-docx-3/file
Implications to Clients
Manufacturers and Authorized Representatives intending to obtain an official product classification should ensure they are prepared to use the new Online Product Classification Application System effective 1 August 2026.
Any internal procedures that reference the previous Google Form submission process should be updated accordingly.
Companies should ensure that the email address provided during submission is accurate, as all approved Product Classification Letters will be delivered electronically.
Organizations are encouraged to familiarize themselves with the new system and review the official user guideline to minimize submission errors and avoid delays.
Effective Date
1 August 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.