The Medical Device Authority (MDA) of Malaysia has released the Second Edition Guidance Document, MDA/GD/0043 Mei 2025: Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, for public comment.
This document is intended to replace the previous edition, MDA/GD/0043 May 2020: Special Access – Notification – General Requirements. The revised guidance provides an updated and comprehensive framework for managing unregistered medical devices under the Special Access Exemption, as defined in the Medical Device (Exemption) Order 2024.
The guidance outlines eligibility, notification procedures, and applicant responsibilities for unregistered medical devices under special access and invites stakeholder feedback to ensure it meets industry and regulatory standards.
The public comment period is open from 28 April to 7 May 2025. Feedback should be submitted using the provided public comment form to anissuhaila@mda.gov.my or nursyaza@mda.gov.my by 7 May 2025.
Access the full document here:
Second Edition Guidance Document, MDA/GD/0043 Mei 2025: Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application [PDF]
Older Edition, MDA/GD/0043 May 2020: Special Access – Notification – General Requirements [PDF]
The announcement is available in both English and Malay:
This Guidance Document should be read in conjunction with the current laws and regulations in Malaysia, including but not limited to:
- Device Act 2012 (Act 737) ;
- Medical Device Regulations 2012;
- Medical Device (Exemption) Order 2024.
Key Highlights
Comparison between MDA/GD/0043 Mei 2025: Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application and previous edition, MDA/GD/0043 May 2020: Special Access – Notification – General Requirements.
| Feature | 2020 Edition | 2025 Edition |
|---|---|---|
| Legal Reference | Medical Device (Exemption) Order 2016 | Medical Device (Exemption) Order 2024 |
| Process Type | Outlined general notification procedures with two routes: Route A (emergency) and Route B (compassionate, stock-out, enhanced procedure) | Detailed application process with a normative annex (Annex A) illustrating the process flow |
| Submission Mechanism | Manual form submission via email | Online application through the MeDC@St system |
| Submission Mechanism | Outlined general notification procedures with two routes: Route A (emergency) and Route B (compassionate, stock-out, enhanced procedure) | Outlined general notification procedures with two routes: Route A (emergency) and Route B (compassionate, stock-out, enhanced procedure) |
| Application Evaluation | Reviewed by MDA with a ‘No Restriction Letter’ issued upon receipt of the RM300 administrative charge | MDA review will be completed within 14 working days upon receipt of the administrative charge of RM300 |
| Annexes | Five Annexes: Annex A: Notification procedure Annex B: Notification of Medical Devices for Special Access (Route A) Annex C: Notification of Medical Devices for Special Access (Route B) Annex D: Disposal of medical device for special access Annex E: List of recognised foreign regulatory authorities and respective approval types | Four Annexes: ANNEX A (normative): Process Flow for Special Access Medical Device Application ANNEX B (normative): Information requirements as outlined in the MeDC@St ANNEX C (normative): Template Healthcare Professional Request Letter ANNEX D (normative): Disposal Form of Medical Device for Special Access |
| Labelling | Met all the labelling requirements set out in the Sixth Schedule of the MDR 2012 and required special access identification and limitation to practitioner’s care | Required Special Access Medical Device label and a statement that it shall be used only by a medical practitioner for a patient under his care |
| Post-handling | Mandatory disposal form (Annex D), shall be endorsed by the healthcare facility where the medical device was supplied or used; disposal notice no later than 30 days from end of the special access | Same requirement, but form and process clarified with more structured record-keeping and disposal/export options |
| Administrative Fee | RM300 via bank draft (manual) | RM300 via BayarNow portal (digital) |
| Regulatory Oversight Emphasis | Broad conditions; flexibility in emergencies | Stronger traceability, electronic documentation, and clearly defined applicant responsibilities |
| Normative Annexes | Annexes B/C tailored per route | Unified format based on MeDC@St system and regulatory annexes |
Comparison of Annexes: 2020 vs. 2025 Editions
| Annex | 2020 Edition | 2025 Edition | Key Changes and Highlights |
|---|---|---|---|
| Annex A | Flowchart: Notification Procedure for Routes A & B | Process Flow for Special Access Medical Device Application | Revised to reflect a centralised application workflow, replacing Route A/B distinction with a unified digital pathway via MeDC@St |
| Annex B | Notification Form for Route A – includes detailed section-wise input for device, practitioner, clinical rationale, and safety data | Information requirements as outlined in the MeDC@St | Transformed into a structured online application interface with embedded validation. Manual forms are no longer used; instead, real-time data input and document upload via MeDC@St are mandated |
| Annex C | Notification Form for Route B – similar to Annex B but tailored for stock-out, compassionate use, or enhanced procedure scenarios | Template Healthcare Professional Request Letter | Route-specific manual forms are eliminated. Instead, a standardised letter template from the requesting healthcare professional is introduced, to be printed on official letterhead and uploaded to MeDC@St |
| Annex D | Disposal Form for Medical Devices after Special Access Ends (manual PDF submission) | Updated Disposal Form for Post-Handling Action | Still required, but modernised with structured tracking fields including mode of disposal (local, export, destroyed), declaration statements, and application IDs. Submission now via email with tighter traceability and a compliance checklist |
| Annex E | List of recognised foreign regulatory authorities (e.g. FDA, TGA, EU Notified Bodies) | Removed from annexes; now referenced via Circular Letter No. 1/2025 | Recognition of foreign authorities has been decoupled from the annex and is now maintained separately in official MDA circulars, allowing dynamic updates without amending the guidance document |
Implications to Clients
Clients must ensure the following:
- Understand and comply with the updated guidance when dealing with unregistered medical devices under the Special Access Exemption.
- Submit complete and accurate notifications to MDA promptly to prevent delays or rejections.
- Maintain thorough records for all unregistered medical devices imported or supplied under this exemption, including evidence of the necessity for special access and records of device performance and safety.
- Participate in the public comment process to voice concerns, suggest improvements, and contribute to the development of practical and effective regulatory guidance.
Effectivity Date
The public comment period is active from 28 April to 7 May 2025. The finalised guidance will be published and enforced following MDA’s review and approval of all feedback received.
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