On January 27, 2026, the Medical Device Authority (MDA) of Malaysia hosted the “Shaping What’s Next 2026” ceremony in Putrajaya. The Chief Executive presented a comprehensive review of 2025 achievements and outlined the strategic roadmap for 2026.
- 2025 Performance Review: Global Leadership in Efficiency
MDA demonstrated world-class regulatory efficiency in 2025, maintaining a 95% adherence rate to established processing timelines.
- Premarket Success: Registered 14,446 medical devices and approved 3,707 establishment licenses, marking the highest volume in ASEAN and a leading figure globally.
- Approval Timelines: Turnaround targets: 1–14 days for Class A devices and 21–30 days for Class B, C, and D devices (subject to complete documentation).
- Infrastructure: Approved 11 Conformity Assessment Bodies (CABs) to enhance local assessment capacity.
- Trade Impact: Malaysia saw RM 137.7 billion in exports versus RM 30.6 billion in imports (2021–2024), supported by 754 Certificates of Free Sale (FSC) issued in 2025.
- International Collaboration & Reliance
Malaysia strengthened its position as a regional hub through strategic partnerships and leadership roles.
- Global Leadership: Malaysia was appointed as the Chair of the Global Harmonization Working Party (GHWP).
- Strategic MoUs: Signed agreements with Uzbekistan (CPPS) —creating a pathway for MDA-approved devices into others Central Asia countries—as well as Singapore (HSA) and Thailand (Thai FDA).
- Reliance Programs: Launched the Phase 1 Reliance Program in collaboration with China’s NMPA, Singapore’s HSA, and the Thai FDA to facilitate expedited mutual market access during the designated monthly pilot program period.
- Enforcement and Post-Market Surveillance
MDA maintained a rigorous oversight environment to ensure public safety in 2025.
- Premise Inspections: Conducted 195 inspections and 2 raid operations, resulting in 4 revoked and 5 suspended establishment licenses.
- Market Monitoring: Monitored over 4,000 advertisements, resulting in 7,082 takedowns.
- Quality Control: Managed 829 Problem Reports (MPR), 315 Field Corrective Actions (FCA), and 72 Recalls.
Strategic Planning for 2026: The Digital & Technical Roadmap:
The Authority is shifting toward advanced digitalization and refined technical oversight.
Technical & Policy Enhancements
- E-Labelling & UDI: Implementation of Electronic Labelling (upcoming month) and the Unique Device Identification (UDI) policy.
- AI & Software: Finalizing specific guidance documents for AI/ML and Software-embedded medical devices.
- Usage & Maintenance: Developing regulations under Section 43 of Act 737 regarding evidence of competency (Target: June 2026).
- Designated Medical Devices (DMD): Finalizing regulations for beauty and cosmetic devices, i.e. Lasers.
Digital Transformation (MEDCAST 3.0)
- Security: Launching MEDCAST 3.0 in 2026, featuring upgraded identity authentication and real-time verification.
- Rollout: Phase 1 (June 2026) will digitalize Establishment Licensing, Product Registration, CAB applications, and Change Management.
Future Reliance & Global Outreach
- Expanded Reliance: Initiating activities with Egypt, Indonesia, Oman, Brazil, India, UAE, and Russia.
- ASEAN Joint Assessment: Discussions are underway for a Joint Assessment program between Malaysia, Singapore, Thailand, and Indonesia.
- EU MDR Compliance: Enabling SIRIM and KGS to be recognized as a partner to EU Notified Bodies based in Turkey to conduct assessment in Malaysia.
MDA Academy
- Establishment of the GHWP Academy and MDA Academy to provide professional training and updated regulatory education for the industry
In conclusion, Malaysia is strengthening its global influence as the Chair of the GHWP by expanding international reliance programs with countries such as China, Singapore, and Brazil, while establishing the MDA Academy to serve as a premier regional training hub for medical device professionals.
Implications to Clients: Building on its 2025 success as a regional leader in regulatory efficiency, the MDA is advancing toward 2026 by implementing digital transformation through MEDCAST 3.0, expanding international reliance programs with key global partners, and establishing the MDA Academy to solidify Malaysia’s position as a premier hub for medical device excellence. Furthermore, for manufacturers who have not obtained approval from traditional reference countries, MDA is introducing new market pathways through the expansion of its Phase Reliance Programs.
Effective Date: Not applicable, this document serves as a comprehensive summary of the MDA’s achievements in 2025 and their strategic roadmap for 2026.
