Malaysia MDA 2026 Update on Class A Medical Device Fees

Malaysia’s Medical Device Authority (MDA) has announced new application and registration fees for Class A medical devices, effective 1 January 2026, under the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330].

Understanding these changes is crucial for medical device manufacturers planning to register or renew Class A products in Malaysia’s regulated medical device market.

Key Updates Effective 2026

Until 10 December 2025, Class A devices are charged an RM 100 application fee with no registration fee. From 1 January 2026, the following new fee structure applies:

Any application submitted after 10 December 2025 will fall under the new fee schedule. Applications received on or before that date remain eligible for the existing RM 100 rate with no registration charge.

Impact on Medical Device Manufacturers

This marks the first increase in Class A device fees since the 2012 Medical Device Regulations. The introduction of a registration fee signals MDA’s shift toward a cost-recovery model, supporting sustainable oversight and post-market surveillance.

For manufacturers, this means:

• Higher upfront costs for low-risk device registrations

• A need to budget ahead for 2026 applications

• Submitting early to secure the lower fee before December 2025

Manufacturers with multiple Class A devices should assess their portfolios now to optimize submission timing.

Actions to Take Before December 2025

1. Submit early: file pending Class A applications before 10 December 2025 to benefit from the current RM 100 rate.

2. Plan budgets: include the RM 500 + RM 750 fees in 2026 cost forecasts.

3. Update internal processes: align your regulatory team and authorised representatives with the new cost model.

4. Monitor MDA announcements: follow MDA’s official portal for future implementation guidance.

For broader context, see also:

• MDA Malaysia Medical Device Registration

• MDA Malaysia Medical Device Classification

Why This Matters

The amendment under P.U.(A) 330 revises the Fifth Schedule of the 2012 Regulations, aligning Malaysia’s model with regional cost-recovery practices. Adding a registration fee for Class A devices brings the fee structure closer to that of higher-risk device categories, promoting fairness and funding continuous regulatory monitoring.

Conclusion

The Malaysia MDA Class A Fee Update 2026 increases the application fee to RM 500 and introduces a RM 750 registration fee, effective 1 January 2026.

Manufacturers should submit before 10 December 2025 to retain the lower cost and prepare early for the new regime.

For full details, refer to the official notice: Medical Device (Amendment) Regulations 2025 [P.U.(A) 330]

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