The Medical Device Authority (MDA) of Malaysia has officially gazetted the Medical Device (Amendment) Regulations 2025 [P.U. (A) 330] on September 11, 2025.
This amendment revises the fee structure under the Fifth Schedule of the Medical Device Regulations 2012 [P.U. (A) 500/2012] for the registration of Class A medical devices, effective January 1, 2026.
To read the full announcement:
https://portal.mda.gov.my/index.php/announcement/1653-pengumuman-penting-peraturan-peraturan-peranti-perubatan-pindaan-2025-p-u-a-330-important-announcement-medical-device-amendment-regulations-2025-p-u-a-330
Key Highlights
Application Fee
- Revised from RM 100 to RM 500 for Class A medical devices.
Registration Fee
- Set at RM 750 for Class A medical devices.
Effective Date
- The revised fees apply to all new and re-registration applications submitted on or after January 1, 2026.
Final Submission Date for 2025 Applications
- Applications under the current fee structure must be submitted and paid by December 10, 2025.
Implications to Clients
Higher Costs
- Applications submitted on or after January 1, 2026, will be subject to the increased fees for Class A device registration.
Timeline Adjustment
- Stakeholders are advised to plan submissions early to meet the December 10, 2025 cut-off date and avoid transition delays.
Compliance
- Establishments should review the updated Fifth Schedule of the Medical Device Regulations 2012 and align internal processes to comply with the revised fee requirements.
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