On September 11, 2025, the Medical Device Authority (MDA) of Malaysia updated the application and registration fees for Class A medical devices in accordance with the Medical Device (Amendment) Regulations 2025 [PU(A) 330].
The revised fees will take effect from January 1, 2025.
The updated fees are as follows
1) Application fee for Class A medical device registration: 500 RM
2) Approval fee for Class A medical device: 750 RM
The final submission and payment deadline for all Class A medical device applications for 2025 is December 10, 2025. Any applications received after this date will be reviewed in January 2026 and will be considered as applications for 2026.
Please refer to the attached document below.
If you have any questions about medical devices,
please contact us with the below.
ra@jnmglobal.net
info@jnmglobal.net