Malaysia Medical Device Import Permit: Timeline, Fees and ePermit

1. Key takeaways

Medical devices in Malaysia are being brought within the import permit system established by the Customs (Prohibition of Import) Order 2023, with the MDA acting as the designated government agency responsible for issuing permits. The original enforcement date of 2 January 2026 was deferred: on 1 December 2025 the MDA announced that mandatory enforcement moves to 1 July 2027. Until then, imports continue under the existing customs declaration process.

• The legal basis is a customs instrument, not a device regulation. The Customs (Prohibition of Import) Order 2023 places medical devices under import permit control, and the MDA issues the permit as the designated agency.
• Enforcement starts on 1 July 2027. The earlier date of 2 January 2026 no longer applies following the MDA announcement of 1 December 2025.
• A voluntary window opens on 1 June 2026. From that date a verification slip may be submitted through ePermit for non-medical devices that fall within medical device tariff codes.
• Fees are modest but per consignment. The import permit application fee is RM130 per consignment and the verification slip is RM50, with fee relief arrangements during the transition period subject to the announcement in force.
• Timing is process-driven. Applications should be lodged no later than seven days before shipment, and standard processing takes three working days, with expedited handling available.
• A permit is not a registration. The import permit authorises a shipment; product registration remains the precondition for market access, and the two regimes run in parallel.

2. Legal basis

The enabling instrument is the Customs (Prohibition of Import) Order 2023. It brings medical devices within the import permit regime, and the MDA is designated as the government agency responsible for issuing the permit. A list of HS codes accompanies the regime and is used to identify which goods are treated as medical devices for this purpose. Because the obligation is created by a customs order rather than by Act 737, the permit requirement operates at the border and on a consignment basis, independently of the registration status of the product.

The transition is structured in two stages. During the period before 1 July 2027, imports continue to follow the current customs declaration process, so the permit is not yet a border requirement. Within that period, from 1 June 2026, a voluntary route becomes available: a verification slip may be submitted through the ePermit system at newepermit.dagangnet.com.my for non-medical devices that fall within medical device tariff codes. The voluntary route is a rehearsal mechanism, allowing importers to test classification and system access before the requirement becomes mandatory.

Fees and processing follow the published workflow. The import permit application fee is RM130 per consignment and the verification slip is RM50, with fee relief arrangements during the transition period, subject to the announcement in force at the time. The sequence is an ePermit submission, lodged no later than seven days before shipment as a working recommendation, with standard processing of three working days and expedited handling available. HS codes apply to all submissions, which means classification is a prerequisite for every filing rather than a detail that can be settled at the border.

The relationship with registration is cumulative, not alternative. An import permit is an authorisation at the level of an individual shipment; product registration is the condition for placing a device on the market at all. Holding a permit does not cure an unregistered product, and holding a registration does not remove the need for a permit once enforcement begins. The two systems run side by side, and each must be satisfied on its own terms.

3. Expert insights

Deferrals are useful but they compress work rather than remove it. The move from 2 January 2026 to 1 July 2027 creates a period in which the requirement is known but not yet enforced, which is precisely the condition under which preparation is postponed. The voluntary window from 1 June 2026 exists to prevent that outcome, and it is worth treating as the real deadline: an organisation that has run a verification slip has already tested its HS classification, its account structure and its internal approval flow, while an organisation that has not is still working from assumptions.

HS classification is where the practical difficulty sits. The regime identifies medical devices by code, so a product that is a device in substance but sits outside the listed codes may not be captured, and a product that is not a device may fall inside a listed code and be captured anyway. That asymmetry is why the voluntary route is expressly available for non-medical devices that fall within medical device tariff codes. Classification errors produce either an unnecessary filing or a missed one, and both are correctable only if they are found before the consignment moves.

The account architecture is the second under-prepared area. ePermit distinguishes between a Super User, Sub Users and freight forwarder access, and each role carries different permissions. Building that structure after enforcement begins means building it under time pressure, with shipments waiting. Building it during the voluntary period means the structure is already tested when it becomes mandatory.

4. Practical recommendations

• Map every product to its HS code now, and confirm each classification with the customs broker item by item rather than by product family.
• Stand up the ePermit account structure during 2026, covering the Super User, Sub Users and freight forwarder access, and document the internal approval steps as a written SOP.
• Run at least one verification slip through the voluntary route after 1 June 2026, so that the workflow, the fee payment and the response handling are proven before enforcement.
• Build the seven-day lead time into shipping schedules and confirm whether three working days of standard processing is sufficient for your release cycle, or whether expedited handling is needed.
• Separate the import permit budget from the registration budget. The permit fee is charged per consignment, so volume drives the cost rather than the number of products.
• Do not allow a permit to be treated internally as evidence of registration. Keep the two approvals on separate lines in the shipment release checklist.

5. Verification checklist

• □ Confirm the MDA announcement Update on the Enforcement Date for Medical Device Import Permit, dated 1 December 2025.
• □ Confirm the scope of the Customs (Prohibition of Import) Order 2023 and the accompanying HS code list.
• □ Confirm the ePermit system access details at newepermit.dagangnet.com.my.
• □ Confirm the fee and processing figures of RM130, RM50, three working days and seven days against the current MDA guidance, noting that these were compiled from published summaries by licensed consultants including Asia Actual and ARQon and are indicative.
• □ Confirm that product registration remains a separate precondition independent of any import permit.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Malaysia. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the MDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com