1. Background

On 11th September 2025, the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330] were officially gazetted. An amendment has been made to the Fifth Schedule of the Medical Device Regulations 2012 [P.U. (A) 500/2012], which revises the application and registration fees for Class A medical devices. The new fee structure will take effect on or after 1 January 2026.

 

2. Revised Fee Structure

Type of Fee	Application fee		Registration fee
	Before	After	Before	After
Fees	-	RM 500	RM 100	RM 750

 

3. Submission Timeline

The new fee structure will apply to all new registration and re-registration applications for Class A medical devices. The final submission date under the 2025 fee structure is 10 December 2025. Applications submitted after this date will be reviewed in January 2026 and will be considered 2026 applications, subject to a new fee. This deadline is essential to ensure timely processing and accommodate the necessary internal transition.

 

4. Stakeholder Impact

Under these changes, all stakeholders including manufacturers, authorized representatives, importers, and distributors must ensure compliance with the revised fee structure outlined in the amended Fifth Schedule of the Medical Device Regulations 2012 before the effective date.

 

Need Support with the 2026 Fee Transition?

Our regulatory experts are ready to help you adjust to the new Class A fee structure and plan future submissions efficiently.

Qualtech Consulting Corporation has supported medical device manufacturers for over 25 years.

Connect with us today to ensure smooth regulatory compliance and unlock your device’s potential.

 

Reference

AMENDMENT REGULATIONS 2025 [P.U. (A) 330]-CLASS A CHANGE PAYMENT FEE