The Medical Device Authority (MDA) of Malaysia, under the Ministry of Health, has introduced a guidance "Importation of Medical Devices for Re-Export (IRE)" detailing the regulatory requirements for the importation of medical devices intended for re-export (IRE). This guidance outlines the application process, approval requirements, and compliance conditions that companies must follow when importing medical devices into Malaysia for maintenance, testing, sterilization, packaging, labeling, distribution, or other specified purposes before exporting them again.
IRE Approval Letter:
A formal authorization issued by MDA allows a company to import medical devices for re-export without requiring full registration under Act 737.
Under Malaysia’s Medical Device Act 2012 (Act 737), medical devices imported for the local market must be registered with the MDA. However, certain medical devices not intended for sale in Malaysia but temporarily imported for processing and re-export may be exempted from registration, provided they meet specific criteria.
To facilitate this, the MDA has introduced the Import for Re-Export (IRE) Approval System, which grants companies an IRE approval letter. This permits the import and re-export of medical devices without formal registration, provided that companies comply with the required conditions.
The IRE exemption applies to all medical devices, including in vitro diagnostic (IVD) devices, that are imported into Malaysia for specific processing activities such as:
Maintenance and servicing
Testing and calibration
Sterilization procedures
Repackaging and relabeling
Storage and distribution via logistics hubs
However, the IRE exemption does not apply to:
Medical devices classified as Export-Only Products (covered under MDA/GD/0051)
Medical devices for clinical research or performance evaluation (covered under MDA/GD/0016)
Companies seeking IRE approval must follow a structured application process and submit the Application for Import for Re-Export Medical Device Form (Annex B of the guidance).
The application must include:
Company details, including business registration information and the designated responsible officer.
Medical device details, including name, brand, model, intended use, manufacturer details, and quantity.
Supporting documentation, such as service agreements, packaging instructions, or distribution hub contracts.
Declaration by the applicant, confirming that the imported medical device will not be placed on the Malaysian market.
The application must be submitted at least 21 days before the intended importation date via email to exemption.bhai@mda.gov.my.
Once the application is received, the MDA will verify the completeness of the submitted documents, assess compliance with exemption requirements under Act 737, and Issue the IRE approval letter if all requirements are met.
Applications are processed in approximately 14 working days. If additional information is requested, applicants have 30 days to respond. Failure to provide the requested details within this period may result in the automatic withdrawal of the application.
The IRE approval letter is valid for 12 months and covers multiple shipments within the approval period. All imported medical devices must be exported before the approval letter expires. If the export process is delayed, companies may request an extension using the Subsequent Application for Import for Re-Export Medical Device Form (Annex D).
Once the medical devices have been successfully exported, companies must submit a Declaration on Import for Re-Export (Annex C) within 30 days of exportation. The IRE approval system provides significant advantages for medical device manufacturers and distributors, including:
Faster regulatory processing for import and re-export activities.
Flexibility in managing international supply chains.
Reduced administrative burdens by waiving full registration requirements.
Alignment with global medical device regulations, ensuring compliance with international trade standards.
For full details, visit: Medical Device Authority (MDA) Malaysia
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