On March 11, 2025, the Medical Device Authority (MDA) of Malaysia released the First Edition Guidance Document MDA/GD/0069 titled “Importation of Medical Devices for Re-Export (IRE).” This document provides clarity on the procedures and requirements for importing medical devices into Malaysia for re-export purposes, covering aspects such as approvals, exemptions, and compliance obligations.
Key Highlights
- Exemption from Registration: Medical devices imported for re-export, including those for maintenance, testing, sterilisation, packaging, or distribution, are exempt from registration under the Medical Device Act 2012 (Act 737).
- IRE Approval Requirement: Companies must obtain an IRE approval letter from MDA before importing medical devices for re-export.
- Scope of Application: The guidance applies to all medical devices, including in vitro diagnostic (IVD) devices. However, it excludes devices intended solely for export (MDA/GD/0051) and Research Use Only devices (MDA/GD/0016).
- Applicant Requirements: Eligible applicants include registered companies, licensed establishments, and forwarding agents in Malaysia. Applications must be submitted at least 21 days before importation.
- Application Process:
- Submit the IRE Application Form via email.
- MDA reviews and issues an approval letter within 14 working days.
- Approval is valid for 12 months and allows multiple shipments.
- Extension of IRE Approval: If export cannot be completed within the approval period, a 6-month extension may be requested at least 14 working days before expiry.
- Post-Importation Requirements:
- A declaration of import/export records must be submitted within 30 days after export.
- Records must be available for inspection by MDA.
- Conditions for IRE Approval:
- Re-exportation: Devices must be re-exported before the approval expires.
- Validity: The IRE approval is only valid for the approved device and site.
- Non-compliance: Non-compliance with the conditions can lead to the revocation of approval, fines, or imprisonment.
- Advertising: Advertising of the IRE approval is strictly prohibited.
Implications to Clients:
Companies must ensure strict compliance with the Medical Device Act 2012 (Act 737) and the IRE approval process. Misuse of IRE approval, such as using it to place medical devices on the local market, is a serious offense under the Act, with penalties of up to RM200,000 in fines, three years imprisonment, or both.
For full details, refer to the official document: Medical Device Guidance Document.
For inquiries, contact us at sales@andamanmed.com or click the button below.
For full details, refer to the official document: Medical Device Guidance Document.
For inquiries, contact us at sales@andamanmed.com or click the button below.
