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Medical Device Management in Healthcare Facilities

MMDA representatives attended the “Medical Device Management in Healthcare Facilities” workshop on 28 May 2025 at the Seminar Room, Ground Floor (Aras G), MDA. The workshop served as a platform to exchange views and gather stakeholder input on healthcare facility practices related to medical device lifecycle management, aligned with the intent of Section 43, Act 737. A key focus was the practical management of medical devices categorised as Orphaned, Obsolete and Discontinued (OOD), which remains a significant challenge for facilities working to maintain safe, consistent and quality healthcare services.

Key topics highlighted

Discussions emphasized the importance of healthcare facilities having clear internal procedures that support safe and accountable device use throughout the lifecycle. Among the operational areas discussed were:

  • Testing & Commissioning 

  • Management of warranties

  • Schedules Maintenance

  • Unscheduled Maintenance

  • Incidents, Investigation and reporting

  • Alerts, safety, FSCA and recall notices

  • Decommissioned active MD

  • Disposal of active MD

  • Uptime

Industry clarification: discontinued/obsolete device control guidance

From an industry standpoint, a helpful clarification shared during the engagement was that actions related to discontinued products are understood to be situational rather than universal. Specifically, where a product is discontinued and no longer re-registered under the relevant certificate, but an establishment still needs to supply it (for example, to support existing inventory or loan arrangements), a declaration process may apply. Conversely, where an establishment no longer supplies the discontinued product, the declaration would generally not be required. Stakeholders also noted that further updates are anticipated following review of feedback received through the public comment process on the related guidance document.

Appreciation

Our Association welcomes the continued engagement between regulators, healthcare facilities and industry to strengthen consistent practices for medical device management—particularly for OOD devices—and to support safe, sustainable healthcare delivery. We thank MDA and all participants for the constructive dialogue and shared commitment to improvement.

Get in Touch

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No: 17, Jalan SS7/26, Kelana Jaya, 47301 PJ, Selangor Darul Ehsan

T: (03) 7804 4468
E: secretariat@mmda.org.my

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