Malaysia Medical Device Registration and Licence Fees

1. Key takeaways

Official fees for medical device work in Malaysia come from a single schedule and are therefore predictable, which is not true of the service costs that surround them. Registration fees are set by the Fifth Schedule to the Medical Device Regulations 2012, as amended by P.U.(A) 330/2025 with effect from 1 January 2026. Establishment licence fees sit in the same schedule. Everything else, from CAB assessment to GDPMD audits, is quoted commercially and varies by provider and by scope.

• The schedule is the reference point. Registration and licence fees are prescribed, not negotiated, and the amounts are published.
• Class A now carries two components. From 1 January 2026 the Class A application fee is RM500 and a registration fee of RM750 applies, bringing the total to RM1,250 per device.
• Payment discipline is strict. Fees are payable within 30 days of the payment notice, and an application that is not paid in time is deleted from the system.
• One instrument per category. Payment is by bank draft only, drawn in favour of KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN; cash is not accepted, and fees for different categories or applications cannot be combined on one draft, with a maximum of five applications per draft.
• Fees are non-refundable. The schedule provides that all fees are non-refundable regardless of the MDA decision.
• Budget the surrounding costs separately. CAB assessment, AR service fees, GDPMD audits and, from July 2027, import permit related charges must be confirmed in writing item by item.

2. Legal basis

The Fifth Schedule to the Medical Device Regulations 2012 prescribes the fees, and the figures below reflect the amendments made by the Medical Device (Amendment) Regulations 2025, cited as P.U.(A) 330/2025, which apply from 1 January 2026. Each row separates the application fee from the registration fee, because the two are charged at different points in the process even though both are payable for a complete registration.

Establishment licence fees are set in the same schedule. The application fee is RM250 for a new application and RM200 for renewal, and it is the same for all four categories of establishment. The licence fee then depends on the role.

Four payment rules govern how the fees must be discharged. First, payment must be made within 30 days of the payment notice; if it is late, the application is deleted from the system, which means the file must be started again rather than simply settled late. Second, the MDA accepts bank drafts only, drawn in favour of KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN, and does not accept cash. Third, fees for different categories or different applications must not be combined on a single draft, although up to five applications may be combined on one. Fourth, all fees are non-refundable, whatever the MDA decides on the application.

Beyond the official fees, the cost base includes items that the schedule does not fix. CAB assessment fees vary substantially by conformity assessment body and by device class, and must be obtained as a separate quotation. AR annual service fees are commercial. GDPMD audit fees are charged according to the site or sites involved. Import permit related charges arise from July 2027 under the separate import permit regime. Because market quotations for these items differ widely, each should be confirmed in writing rather than estimated from experience.

Where a budget is expressed in renminbi, conversion should be made at the prevailing rate, with the caveat that exchange rates move and any converted figure is indicative only. The official fee component can be treated as transparent and lockable, since it is published. The service component is better compared on an itemised basis separating official fees from professional fees, so that the composition of a packaged price remains visible.

3. Expert insights

The introduction of a registration fee for Class A changes the economics of large portfolios more than the headline increase suggests. Previously, the official cost of a Class A registration was limited to the application fee. From 1 January 2026 both components apply, so the marginal official cost per device rises to RM1,250. For a manufacturer holding dozens of Class A devices, that marginal figure, multiplied across the portfolio, is the number that matters, not the unit change.

This is also why grouping rules deserve attention before the budget is fixed. Where a reasonable grouping can cover multiple variants under one registration, the official fee is incurred once rather than once per variant. The saving is not a discount; it is the correct application of the grouping provisions in the Second Schedule. Manufacturers that bypass grouping and file each variant separately pay the schedule in full, repeatedly.

The payment rules are operationally trivial until they are not. A draft drawn in the wrong name, or a combined draft covering two categories, is rejected, and the 30-day clock does not pause while the instrument is reissued. Because late payment results in deletion rather than suspension, the practical consequence is a lost place in the queue and a rebuilt file. Finance teams that treat the payment notice as an ordinary invoice tend to discover this once.

4. Practical recommendations

• Build an official fee budget table by class, multiplying the number of SKUs by the sum of the application fee and the registration fee, and refresh it whenever the schedule changes.
• Screen SKU necessity before filing. From 2026, with Class A charged in two components, retiring low-value SKUs produces a direct saving against the schedule.
• Apply the grouping rules in the Second Schedule deliberately, so that one reasonable grouping covers multiple variants instead of generating parallel applications.
• Issue bank drafts in the exact name required, one category per draft, and cap consolidation at five applications. Diarise the 30-day payment window from the date of the notice.
• Request itemised quotations for CAB assessment, AR services and GDPMD audits, and keep official fees and professional fees on separate lines so that tender comparisons remain meaningful.
• Plan change applications in batches. Fragmented change requests accumulate fees that a planned submission would have avoided.

5. Verification checklist

• □ Confirm the fee amounts in the Fifth Schedule to the Medical Device Regulations 2012.
• □ Confirm the amendments in the Medical Device (Amendment) Regulations 2025, P.U.(A) 330, effective 1 January 2026.
• □ Confirm the payment rules and bank draft details on the MeDC@St section of the MDA website.
• □ Confirm the fee schedule review noted in the MDA announcement FAQ of July 2026.
• □ Confirm the current position as at 19 October 2026 before committing a budget figure.

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