The Medical Device Authority (MDA) has published the draft First Edition Guidance Document (PDF) titled “Application for Confirmation Status of Obsolete and Discontinued Medical Device” for public comment. The guidance outlines the eligibility criteria, application procedures, and the responsibilities and obligations of establishments in managing obsolete and discontinued medical devices.
To access the guidance document (PDF): APPLICATION FOR CONFIRMATION
STATUS OF OBSOLETE AND DISCONTINUED MEDICAL DEVICE
The official Public Comment Form (Borang Ulasan) can be accessed here: [LINK]
Key Highlights
- Purpose of the Document
- To define the criteria and process for confirming the status of obsolete and discontinued medical devices.
- To clarify the obligations of establishments in managing such devices.
- To ensure consistency and transparency in regulatory management of devices that are no longer supplied.
- Public Comment Period
- Duration: 16th – 31st October 2025
- Feedback must be submitted using the official Public Comment Form (Borang Ulasan) as attached.
- Submission Instructions
- Submit completed forms to: guidancedocument@mda.gov.my
- Submission Deadline: 31st October 2025
- Applicable Laws and Regulations
This guidance document should be read in conjunction with:
- Medical Device Act 2012 (Act 737)
- Medical Device Regulations 2012
- Medical Device (Exemption) Order 2024
Implications to Clients
- Stakeholders are encouraged to review the draft and provide feedback within the comment period.
- The finalized document will provide clarity on how to manage and confirm the regulatory status of obsolete and discontinued medical devices.
- Establishments should prepare to align internal documentation and processes accordingly once the final guidance is issued.
Effective Date
To be announced upon official issuance of the final guidance document.
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