MDA Opens Public Comment on Guidance for Orphaned Medical Devices

The Medical Device Authority (MDA) of Malaysia has released the first edition draft guidance document titled “𝘈𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘧𝘰𝘳 𝘊𝘰𝘯𝘧𝘪𝘳𝘮𝘢𝘵𝘪𝘰𝘯 𝘚𝘵𝘢𝘵𝘶𝘴 𝘰𝘧 𝘖𝘳𝘱𝘩𝘢𝘯𝘦𝘥 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦”. It is inviting industry stakeholders to provide feedback.

This document is a significant step toward managing legacy medical devices that remain in healthcare facilities without active manufacturer or Authorised Representative (AR) oversight, ensuring continuity of care while maintaining regulatory accountability.

📅 Public comment period: 16–31 October 2025

📩 Submit feedback to: guidancedocument@mda.gov.my

Understanding Orphaned Medical Devices

In Malaysia, an Orphaned Medical Device refers to a device that is already installed or in use in a healthcare facility but cannot be registered because its manufacturer, AR, or distributor is no longer operating or recognised in the country.

Since the Medical Device Act 2012 (Act 737) prohibits the use of unregistered devices, these orphaned devices present a regulatory gap; many are still essential for patient care. To address this, the Medical Device (Exemption) Order 2024 and this new draft guidance provide a structured pathway for these devices to remain in use legally.

Purpose of the Draft Guidance

The draft guidance establishes a formal application process for healthcare facilities seeking MDA confirmation of an orphaned device’s status. It defines eligibility, procedures, and responsibilities, helping institutions maintain compliance while ensuring patient safety.

Key areas outlined include:

• Eligibility Criteria: Defines the types of devices that qualify for “Orphaned Medical Device” status under the Medical Device (Exemption) Order 2024.

• Application Procedures: Provides step-by-step instructions for facilities applying for confirmation through MDA’s designated system.

• Facility Responsibilities: Transfers responsibility for post-market safety, maintenance, and decommissioning to the healthcare facility itself, including:

• Ongoing risk management and documentation

• Routine maintenance and performance validation

• Safe decommissioning or disposal procedures

• Traceability and recordkeeping

• Importation of spare parts (where necessary)

Implications for Healthcare Facilities and Industry

For healthcare facilities, this framework introduces a new compliance requirement, placing post-market accountability directly on them. Facilities must ensure they have robust Quality Management Systems (QMS), competent biomedical engineering support, and clear documentation processes.

For the medical device industry, the guidance reinforces the need for sustainable representation and continuity planning. When a manufacturer or AR withdraws from Malaysia, the devices they leave behind can become regulatory liabilities. Establishing clear succession or replacement strategies will help mitigate this risk.

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Why Industry Feedback Matters

The public comment period, from October 16 to 31, 2025, provides a limited but important opportunity for stakeholders to ensure that the final version of this guidance is both practical and implementable.

MDA’s approach demonstrates its ongoing effort to balance patient safety with operational realities in healthcare facilities. Stakeholders are encouraged to submit constructive feedback that supports clarity, efficiency, and continued patient care.

🕒 Deadline for submission: 31 October 2025

📧 Send comments to: guidancedocument@mda.gov.my

A Progressive Step Toward Healthcare Continuity

This draft guidance represents another step in Malaysia’s broader commitment to regulatory modernisation and healthcare resilience. By providing a legal and procedural framework for orphaned medical devices, the MDA is enabling continuity of essential medical services while maintaining oversight and accountability.

It is a call to action for hospitals, importers, and manufacturers alike to participate in shaping a sustainable, patient-centred regulatory environment.

Source:

Medical Device Authority (MDA), Ministry of Health Malaysia ; Public Comment Announcement: Application for Confirmation Status of Orphaned Medical Device (October 2025)