Import for re-export: bringing devices into Malaysia only to send them out again.

The IRE route at a glance

All periods in MDA/GD/0069 are working days unless stated. The guidance document does not mention an application fee.

Who the IRE route is for

• Service and repair centres receiving devices from other countries for maintenance, then returning them.
• Contract sterilisation, packaging and labelling sites that process devices for a manufacturer and ship them on.
• Testing laboratories running verification or investigation work on devices that are not registered in Malaysia.
• Regional distribution hubs holding stock in Malaysia for other ASEAN markets. MDA/GD/0069 lets principal and distribution hubs leave the quantity out of the application, in exchange for quarterly import and export declarations.

It is not for devices made in Malaysia purely for export (that is the export-only route and Export Certificate), nor for research-use-only devices (MDA/GD/0016). A device that will be sold or used in Malaysia needs MDA registration.

What goes into the application

1. Applicant details: company, address, whether it is a licensed establishment (and its licence number and role), contract manufacturer or other, the person responsible and a contact person.
2. Purpose and facility: the purpose ticked on the form and the address and person in charge of the facility where the work happens.
3. Supporting documents for the purpose: for repair, testing, sterilisation or investigation, the IFU or package insert and the service provider’s quotation; for packaging or labelling, the IFU or package insert and evidence of the relationship with the other party, such as an authorisation letter, delivery order or ISO 13485 certificate.
4. Attachment 1, the device list: name, brand and model, intended use, manufacturer, HS code and quantity (not compulsory for multiple-shipment hubs).
5. Import details: date of importation, tentative export date, entry point (land, sea, air) and whether it is a single or multiple shipment.
6. Attestation: the person responsible declares the product is a medical device, that it will not be placed on the Malaysian market, and that it will stay on board or at the stated storage address while in Malaysia. A false declaration is an offence under section 76(1) of Act 737 (fine up to RM100,000, up to 2 years’ imprisonment, or both).

The person responsible must be from top management: a proprietor, director, CEO, managing director or general manager, or a manager they authorise.

The conditions on every IRE approval

• Every device must be re-exported before the approval expires.
• The approval covers only the devices and the site address approved.
• MDA may visit or inspect the premises at any time without notice, and may revoke the approval if a condition is broken.
• All documents about the devices are kept at the premises and shown to MDA on request.
• IRE records are kept as part of the distribution records required by the Medical Device (Duties and Obligations of Establishments) Regulations 2019.
• Devices that cannot be re-exported are declared to MDA; excess devices are disposed of under MS 2650.
• The IRE approval may not be advertised (section 44 of Act 737).
• Using the approval to place devices on the Malaysian market is an offence under section 5: a fine up to RM200,000, up to 3 years’ imprisonment, or both.
• Once the approval expires or is cancelled, no further import or export is allowed under it.

Import for re-export vs other routes

The full list of the 12 exemptions in the Medical Device (Exemption) Order 2024 is on our exemptions guide, and every MDA guidance document with its current edition is in our MDA guidance documents index.