Malaysia: MDA Introduces Enhanced Dispute Resolution Process for Medical Device Classification

The Medical Device Authority (MDA) has announced a new enhanced process to facilitate the resolution of classification risk disputes between Establishments and Conformity Assessment Bodies (CABs). This initiative aligns with the Medical Device Act 2012 (Act 737) and aims to improve consistency and clarity in determining the appropriate classification for both General Medical Devices (GMD) and In Vitro Diagnostic (IVD) Devices.

To read more, refer to the official announcement from MDA: Enhanced Process for Managing Classification Risk Disputes Between Establishments and CABs

Effectivity

Effective immediately, as of May 26, 2025.

Key Highlights

• The enhanced process supports transparent and timely dispute resolution between Establishments and CABs.
• Applies to classification risk disputes for both GMD and IVD devices.

Initiating a Dispute Resolution

Stakeholders must follow these steps to submit a dispute:

• Download and complete the Dispute Classification Risk Form. 
• Submit the completed form to the relevant email address based on device type:
  • GMD: registration@mda.gov.my
  • IVD: ivd.registration@mda.gov.my

Implications to Clients

Establishments are encouraged to use this structured process for any classification risk disputes to ensure timely and appropriate resolution in accordance with regulatory expectations.

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