Malaysia Updates Medical Device Procurement Requirements for Healthcare Facilities

The Medical Device Authority (MDA) of Malaysia has issued Circular Letter No. 1/2026, establishing formal procurement requirements for medical devices supplied to healthcare facility institutions under the Medical Device Act 2012 (Act 737). This policy was approved during the MDA Authority Meeting No. 1/2026 and took effect on 28 January 2026.

This Circular Letter marks a significant step in reinforcing regulatory clarity and compliance for all parties involved in tender procurement for medical devices in both the public and private healthcare sectors.

New Procurement Framework for Healthcare Institutions

Under this circular, procurement activities for medical devices through tender processes are now recognised by MDA as part of placing devices in the Malaysian market. As such, companies participating in these activities (tenderers) are required to meet specific regulatory obligations before they can legally supply devices to healthcare facilities.

Key requirements for tenderers include:

• Holding a valid establishment licence to carry out distribution activities as recognised under Act 737.

• Implementing a quality management system aligned with Good Distribution Practice for Medical Devices (GDPMD).

• Assuming full post-market responsibility, including incident reporting, complaint handling, and executing corrective actions or product recalls when necessary.

  
  

These steps reinforce the responsibilities of suppliers beyond registration, ensuring that devices distributed through tenders meet ongoing quality and safety expectations throughout their lifecycle.

Documentation and Tender Obligations

To ensure legal compliance, healthcare facility institutions (both public and private) are now mandated to obtain key documentation from tenderers prior to finalising procurement:

• A copy of the establishment licence for the tenderer as a medical device distributor.

• A copy of the current medical device registration certificate for the relevant product.

• A letter of appointment as a distributor from the authorised representative (AR) or the original establishment.

These documents serve as essential evidence of regulatory compliance and provide assurance that devices being procured and supplied are fully conformant with Malaysian regulatory requirements.

Why This Matters

By clarifying procurement responsibilities for distributors and healthcare institutions, the Circular Letter strengthens regulatory governance across the medical device supply chain. This helps to:

• Mitigate compliance risks associated with procurement of unregistered or improperly supplied devices;

• Increase transparency in supplier qualifications and documentation;

• Enhance patient safety by aligning procurement practices with regulatory expectations;

• Facilitate more robust post-market surveillance and accountability.

  
  

Institutions and suppliers alike should integrate these requirements into their tender planning and compliance strategies immediately, to ensure uninterrupted supply and regulatory conformity.

Looking Ahead

The issuance of Circular Letter No. 1/2026 also revokes the previous Circular Letter No. 2/2016 (Revision 2), reflecting the MDA’s ongoing effort to modernise regulatory instruments in line with evolving market and healthcare needs.

As Malaysia continues to strengthen its medical device regulatory ecosystem, stakeholders are encouraged to prepare early, maintain robust documentation systems, and deepen their understanding of post-market obligations tied to device procurement and distribution.

Source: Medical Device Authority (MDA) Circular Letter No. 1/2026 Procurement of Medical Devices for Healthcare Facility Institutions (effective 28 January 2026)