The Medical Device Authority (MDA) of Malaysia hosted a Facebook Live event on January 14, 2025, titled “Chief Executive New Year Message: What’s Beyond 2025”. Delivered by the MDA Chief Executive, the session highlighted key regulatory and developmental plans for the coming years.
Key Highlights from the Facebook Live Event
Development of MedCast 3.0
MedCast 3.0 will be fully implemented by 2027, with the system released in a staggered manner (first release in 2026).
- Involves 3 Modules:
- Registration: Covers Class A, B, C, and D.
- Establishment License: Streamlined processes.
- CAB: Integrated functionalities.
- Features Include:
- Document submissions via a checklist, reducing approval time from 14 to 10 days.
- Applications will go directly to verification, bypassing the evaluation stage by an officer.
- Automatic renewal every 5 years, with changes allowed before the expiry date.
- CAB reports will be digitalized, with an internal link between CAB and MDA, including GDPMD renewals.
Compounds
- Enforcement of MDA compounds will begin on January 15, 2025.
- Combined Enforcement: Joint efforts by MDA, NPRA, and CKAPS will target public and private hospitals and clinics starting January 15, 2025.
E-Labelling and E-IFU
- To be introduced in 2025.
- Full implementation for all medical devices by the end of 2025 or early 2026.
- Currently applicable to professional-use devices only.
Unique Device Identification (UDI)
- To be implemented for Class D by December 2025, with full implementation by 2026.
- Products with existing EU/US UDI can use the same UDI in Malaysia.
SIRIM-CMI
- MOU expected to be signed in January 2025, enabling EU MDR compliance through SIRIM.
Import Permit
- Pilot project launching in June 2025, with full implementation by January 2026.
- Fee: RM130 per shipment.
Guidance Document
- New and updated guidelines are expected in Q1 2025.
Verification of Reference Countries
- Focus on full Conformity Assessment (CAB).
Innovative Medical Pathway
- Public-private partnership to support Malaysian-made medical devices.
- Contracts will be extended to manufacturers meeting export criteria.
Consensus Framework
- Agreement involving regulators, ministries, and stakeholders to be finalized in 2025.
Introduction of KUSKOP
- Program launching in 2025 to support the upgrading of distributor roles to Authorized Representatives (AR) or manufacturers.
Trade Mission with 4 Countries
- Collaboration with Uzbekistan, Turkey, Qatar, and Kuwait to enhance trade and investment opportunities.
Joint Assessment with China
- Fast-track routes for:
- Malaysian products entering China (Class B).
- Chinese products entering Malaysia (Class C and D).
MDA’s Commitment to Improvement
MDA also announced plans to launch a Regulators One-Stop Centre, which will streamline access to grants, training, registrations, and regulatory information. These initiatives aim to position Malaysia as a leading hub for medical device investment, research, and technology.
Further Information
For additional details, watch the full recording of the live event on Facebook: MDA Facebook Live Broadcast..
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