Malaysia’s 2025–2026 Medical Device Registration Pathway: A Complete Technical Guide For Compliance Under The New MDA Framework

Malaysia’s Medical Device Authority (MDA) has implemented a strengthened 2025–2026 transition pathway designed to modernize the country’s regulatory landscape, improve digitalization, and ensure stronger oversight of medical device safety throughout their lifecycle. These updates significantly influence how manufacturers, Authorized Representatives, importers, and distributors prepare classification requests, manage submissions, conduct conformity assessments, maintain post-market compliance, and handle import activities.

This blog provides a detailed, technically enriched breakdown of the latest MDA requirements and offers strategic guidance for companies aiming for fully compliant, audit-ready registrations in 2025–2026. All insights are presented in a format optimized for SEO, industry searches, and professional regulatory standards.

Major Regulatory Shifts in Malaysia’s Medical Device Registration for 2025–2026

Online-Only Product Classification (Effective 1 May 2025)

Malaysia has moved to a fully digital classification system, eliminating physical submissions. Applicants must now submit requests through the online portal, retrieving classification letters through the same digital interface.

Technical Impact

• Digitized intake ensures faster processing and traceability
• Consistent evaluation across all classes (A–D)
• Electronic classification letter becomes an essential prerequisite for MeDC@St submissions

Compliance Notes

Manufacturers should establish:

• A structured digital repository for classification letters
• Version-controlled documentation aligned with audit expectations
• Cross-checks to ensure device intended use aligns with assigned class

Mandatory Import Permit for Medical Devices (Effective 2 January 2026)

Beginning January 2026, all medical device imports will require a permit under the integrated MDA–Customs ePermit (DagangNet) model.

Technical Implications

• Customs clearance will be linked to device registration validity
• Incorrect HS codes, applicant names, or device lists may lead to shipment holds
• Importers must ensure user-role management within ePermit (Super Users, Sub-Users)

Operational Recommendations

• Activate ePermit profile well before January 2026
• Conduct system simulations and mock submissions
• Submit import permits 3–7 days before shipment to avoid clearance delays

MeDC@St as the Centralized Regulatory Platform

MeDC@St remains the core submission portal but now features updated forms, revised templates, and standardized dossier structures applicable to Class A, B, C, and D devices.

Technical Enhancements

• Improved UI for navigation and documentation uploads
• Updated conformity assessment guides for CAB, verification, and supported foreign evidence
• File size limits updated for technical documents (risk analysis, clinical evidence, IFU, QMS certificates)

Recommended Internal Actions

• Update internal templates for:
  • Device description
  • Essential principles compliance
  • Risk management documents
  • Clinical evaluation reports
• Ensure Authorized Representatives maintain active accounts and follow the newest portal instructions

Expansion of Verification & Regulatory Reliance Pathways

MDA has broadened acceptance of foreign regulatory approvals under verification pathways. Devices approved by recognized authorities may receive expedited review.

Technical Advantages

• Reduced documentary requirements
• Shorter evaluation timelines
• Streamlined conformity assessment

Key Considerations

• Certificates must remain valid during submission
• Foreign approvals must match intended use in Malaysia
• Device configurations must align with global approvals

Updated Rules for Lifecycle Management (2025–2026)

The updated guidelines define requirements for:

• Change notifications
• Design or manufacturing modifications
• Labeling updates
• Re-registration
• Shelf-life extensions
• Manufacturing site additions

Regulatory Impact

• Greater transparency in device evolution
• Clear documentation needed to justify each change
• Stronger post-market auditability

2025–2026 Compliance Checklist for Malaysia Medical Device Registration

Practical Compliance Strategies for Faster Approval in 2025–2026

Strengthen Document Traceability

Maintain a digital archive of classification letters, certificates, test reports, and MeDC@St acknowledgements.

Submit Import Permits Early

Avoid clearance delays by submitting import permits at least a week before shipment.

Aligning Global Certificates with MDA Requirements

Ensure certificate naming, validity dates, and scope match the device’s Malaysian claims.

Prepare UDI and Labeling Readiness

Verify IFU, labels, and packaging content meet the Malaysian market’s language and format expectations.

Audit Your CAB Partner

Confirm your selected CAB remains recognized and active in the MDA system.

Conclusion

Malaysia’s 2025–2026 MDA transition pathway is structured to enhance regulatory transparency, digital efficiency, and lifecycle oversight across the medical device ecosystem. Manufacturers, Authorized Representatives, and importers that proactively adapt to these updates will benefit from faster approvals, reduced compliance risks, and smoother market operations.

By updating SOPs, training teams, strengthening documentation practices, and leveraging regulatory reliance pathways, companies can effectively position themselves for seamless market entry in Malaysia.

Maven Regulatory Solutions supports companies with complete regulatory strategy, MeDC@St submissions, classification, verification pathway assessment, and import permit readiness to ensure full compliance with the new MDA framework.

Frequently Asked Questions (FAQs)

1. Are foreign approvals still accepted by MDA for faster registration?

Yes. Devices approved by recognized foreign regulators may qualify for verification pathways, reducing review timelines.

2. Do all devices require import permits from January 2026?

Yes, all medical devices entering Malaysia will require an MDA-linked import permit.

3. What is the biggest challenge under the new pathway?

Ensuring digital documentation consistency across classification letters, MeDC@St dossiers, and verification evidence.

4. Are labeling and UDI rules updated?

Yes. MDA is increasingly aligning with international standards, requiring precise label formatting and UDI readiness.

5. Who is responsible for maintaining MeDC@St submissions?

Authorized Representatives must maintain active accounts and updated dossiers.