The Medical Device Authority (MDA) of Malaysia has released the Second Edition Guidance Document, MDA/GD/0051 April 2025: Medical Device for the Purpose of Export Only, for public comment. This document is intended to replace the previous edition MDA/GD/0051 April 2019: Notification of Export Only Medical Device. The revised guidance provides comprehensive guidance on the procedures and requirements for exporting medical devices that are not intended for sale or distribution within Malaysia.
The guidance outlines the application process for obtaining the necessary certificates, such as the Certificate of Free Sale for Export Only (CFS EO), and details the responsibilities of manufacturers and exporters in ensuring compliance with the relevant regulations. Stakeholders are encouraged to review the draft and provide feedback to ensure the guidance aligns with industry needs and international 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.
The announcement is available below:
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/0051 April 2025: Medical Device for the Purpose of Export Only and MDA/GD/0051 April 2019: Notification of Export Only Medical Device
| Feature | 2019 Edition | 2025 Edition |
|---|---|---|
| Legal Reference | Circular Letter No. 4/2018 | Medical Device (Exemption) Order 2024 |
| Submission Process | Email submission to MDA | Submission via Google Form or email (exportonly.ec@mda.gov.my) |
| Application Form | Single-device PDF form with manual inputs | Enhanced form with structured fields, plus:• Annex C: Declaration• Annex D: Authorisation Letter |
| 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) |
| Supporting Documents | Catalogues, ISO 13485, LOA (if applicable) | i. ROC certificate ii. QMS ISO 13485 certificate iii. Declaration (Annex C) iv. Authorisation Letter (Annex D) v. Brochures/IFUs/Labels vi. Establishment Licence (if applicable) |
| Application Form Annexes | Annex B: Notification Form | i. ANNEX B (normative): Application Form |
| Feature | 2019 Edition | 2025 Edition |
|---|---|---|
| ii. ANNEX C: Declaration of Compliance iii. ANNEX D: Authorisation Letter Template | ||
| Scope of Application | One notification per device nomenclature | Same – one application per device nomenclature |
| Payment Method | RM500 via bank draft | RM500 via BayarNow online portal (invoice within 1–7 working days) |
| Notification Output | Acknowledgement Notification Letter | Approval Letter issued via email within 14 days |
| Validity Period | 5 years | 5 years (explicitly non-renewable – new application required upon expiry) |
| Submission Timing | Must be before first shipment | Must be approved before export |
| Application Conditions | No defined drop conditions | Application dropped if no response within 14 working days following MDA’s request |
| Declaration Requirements | Simple attestation in form | Annex C: Declaration of Compliance with outlined regulatory obligations |
| Letter Usage Conditions | Allows multiple consignments during validity | Same – but includes new restrictions on advertising, mandatory record-keeping, and audit rights |
Responsibilities of Exporters
Entities seeking to export medical devices under this classification must adhere to the stipulated responsibilities, including:
- Ensuring the safety and efficacy of the devices
- Maintaining proper documentation in accordance with regulatory requirements
Implications to Clients
Clients must ensure the following:
- Understand and Comply with Updated Guidance: Familiarise yourself with the revised requirements for exporting medical devices classified as export only.
- Timely Submission of Applications: Submit complete and accurate applications to MDA early to avoid approval delays or rejections.
- Maintain Thorough Records: Ensure documentation of all exported medical devices, including compliance evidence with the importing country’s regulatory requirements.
Participate in the Public Comment Process: Provide feedback to improve the guidance and ensure practicality in implementation.
Effectivity Date
The public comment period runs from 28 April to 7 May 2025. The finalised guidance will come into effect after MDA reviews submissions and publishes the approved version.
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