Malaysia MDA Announces New Registration Fees for Class A Medical Devices

The Medical Device Authority (MDA) of Malaysia has announced revisions to Class A medical devices registration fees under the Medical Device (Amendment) Regulations 2025 [P.U. (A) 330], gazetted on 11 September 2025. Class A devices, considered low-risk medical devices, include items such as bandages, examination gloves, and simple diagnostic tools.

Effective 1 January 2026, application fees will increase fivefold, and a new registration fee will be introduced, marking a notable update to the registration process for low-risk devices in line with the Medical Device Regulations 2012 [P.U. (A) 500/2012].

Key Amendments

Under the revised Fifth Schedule of the 2012 Regulations, two key adjustments will apply to Class A devices:

The application fee will increase from RM 100 to RM 500.
A new registration fee of RM 750 will be introduced.

This two-tiered structure covers both submission and approval stages, and the new fees will apply to all new and re-registration applications submitted on or after 1 January 2026.

Transition Timeline

To facilitate a smooth transition, the MDA has set 10 December 2025 as the final submission and payment deadline for 2025 Class A medical device applications. The authority will classify applications received after this date under the new 2026 fee structure.

This deadline gives companies time to complete registrations under the current fees and provides the MDA sufficient time to implement the new structure, minimising disruption for both regulators and applicants.

Implications for Industry Stakeholders

While the revisions may appear modest, they have notable operational and financial implications for organisations involved in Class A device registration in Malaysia:

Overseas manufacturers should assess upcoming submission pipelines to determine whether any Class A registrations can be completed before 1 January 2026.
Local Authorized Representatives (ARs) and distributors should prepare for updated invoicing and documentation requirements under the revised structure.
Regulatory affairs teams managing re-registrations should adjust project timelines to meet the 2025 submission deadline and secure approvals under the current fee schedule.

To ensure smooth compliance, overseas manufacturers and other stakeholders should engage early with local ARs or regulatory consultants, making certain all technical documentation meets the MDA’s current requirements.

Final Thoughts

The upcoming revisions to Class A medical device registration fees highlight the need for strategic planning and coordination among manufacturers, distributors, and regulatory partners. By planning ahead and submitting applications before the new fees take effect, companies can manage costs and maintain uninterrupted market access.

With extensive experience across Malaysia, China, and ASEAN markets—and a licensed Authorized Representative (AR) office in Penang—Cisema provides end-to-end support for medical device registration, including:

Preparing and submitting complete MDA registration dossiers
Managing local compliance requirements to ensure ongoing regulatory alignment
Advising on classification, conformity assessment, and regulatory strategy

To submit applications before the new fees take effect and ensure your devices meet MDA requirements with minimal risk of delay, contact Cisema today.