Class A Fee Increase under the 2025 Amendment Regulations

1. Key takeaways

The Medical Device (Amendment) Regulations 2025, cited as P.U.(A) 330, were gazetted on 11 September 2025 and take effect on 1 January 2026. They amend the Fifth Schedule to the Medical Device Regulations 2012 in a way that matters most to portfolios built on Class A devices: the application fee rises from RM100 to RM500, a registration fee of RM750 is introduced where none applied before, and the fee for a change application moves from RM50 to RM500. Class B, C and D fees are untouched.

• Two components replace one. Class A is no longer a single application fee; an application fee and a registration fee now apply together.
• The per-device official cost rises from RM100 to RM1,250. That is the figure to use when rebuilding a budget, not the individual line items.
• Change applications became substantially more expensive. The fee moved from RM50 to RM500, which puts a premium on batching and planning.
• The stated rationale is cost recovery. The official position frames the change as a cost-recovery adjustment that strengthens the funding base for post-market surveillance.
• This is the first adjustment since 2012. Class A fees had not been revised since the regulations were made.
• The cut-off is 10 December 2025. Applications submitted and paid under the old standard by that date were assessed under the old standard; anything received afterwards is assessed on the 2026 basis.

2. Legal basis

P.U.(A) 330/2025 amends the Fifth Schedule to the Medical Device Regulations 2012. Three changes are material. The Class A application fee moves from RM100 to RM500. A registration fee of RM750 is introduced for Class A, so the total official cost per device becomes RM1,250. The change application fee is adjusted from RM50 to RM500. The fees for Class B, Class C and Class D remain as they were.

The stated rationale is a shift to a cost-recovery model, intended to reinforce the funding base for post-market regulation. That framing is consistent with the structure of the amendment: the new registration fee is a second component rather than an increase to the existing one, and the change fee rises by the same order of magnitude as the application fee. The amendment is also the first adjustment to Class A fees since the 2012 regulations, which explains why the movement is large in proportional terms.

Transition is governed by dates rather than by discretion. 10 December 2025 was the cut-off for submitting an application and paying for it under the old standard. Applications received after that date are assessed on the standards applying from January 2026 and are counted as 2026 applications. The new standard applies to all new registration and re-registration applications from 1 January 2026, so an existing certificate coming up for renewal is not insulated by its earlier approval.

The practical effect on a single device is a movement from RM100 to RM1,250 in government cost. For a manufacturer with a broad Class A portfolio, the effect is multiplicative: the same movement applies to every device that is registered or re-registered on the new basis. Class A portfolios therefore need a fresh cost-benefit calculation rather than an inflation adjustment to last year’s budget, because the underlying structure of the charge has changed.

3. Expert insights

The amendment is usually described as a fee increase, which understates what actually changed. A single application fee became a two-stage charge, and the registration fee now attaches to the grant rather than to the submission. For planning purposes the distinction does not matter, since both are payable; for cash-flow purposes it does, because the second component falls due at a later point in the process.

The change fee is the item most likely to be underestimated. At RM50, a change application was cheap enough to be treated as an administrative afterthought. At RM500, a scattering of small changes across a portfolio accumulates into a meaningful line. The rational response is not to avoid changes, which would create compliance exposure, but to consolidate them into planned submissions so that one fee covers a coherent set of amendments rather than several fees covering fragments.

There is also a portfolio question behind the arithmetic. Class A devices often accumulate over time through incremental additions, with each variant registered because it was requested by a distributor rather than because it earned its place. When the marginal official cost was RM100, that accumulation was inexpensive. At RM1,250 per device, the same habit becomes a recurring charge on the annual budget, and the case for pruning becomes financial as well as administrative.

4. Practical recommendations

• Rebuild the 2026 registration budget from the new per-device figure of RM1,250 rather than adjusting the prior year by a percentage.
• Review the Class A SKU list and retire or merge low-value variants. The saving is direct, because each retired device removes one full charge.
• Use the grouping rules in the Second Schedule to cover multiple specifications under one reasonable grouping, so that the fee is incurred once for the group.
• Plan change requirements in advance and submit them together, given that a change application now costs RM500.
• For portfolios weighted towards Class A, such as IVD and consumables manufacturers, carry a separate Malaysia official fee line in the budget and recalculate it on a rolling basis as the SKU count changes.
• Check the re-registration position early. Certificates due for renewal after 1 January 2026 are assessed on the new standard, so the timing of a renewal has a direct cost consequence.

5. Verification checklist

• □ Confirm the text of P.U.(A) 330/2025 as published in the UKK file on the MDA website.
• □ Confirm the effective date of 1 January 2026 and the gazette date of 11 September 2025.
• □ Confirm the MDA announcement titled Important Announcement: Medical Device (Amendment) Regulations 2025 [P.U.(A) 330].
• □ Confirm in MDA/GL/08 that re-registration applications are subject to the new standard.
• □ Confirm the transition commentary published in the Journal of Medical Device Regulation in 2025.
• □ Confirm the current position as at 19 October 2026 before relying on any of the above dates.

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