Malaysia’s Medical Device Authority (MDA) has introduced a revised 2025–2026 transition pathway to strengthen the country’s medical device regulatory framework, streamline conformity assessment requirements, and improve market oversight. The updated pathway brings clearer expectations for manufacturers, Authorized Representatives, importers, and distributors seeking to register or maintain medical devices in the Malaysian market.
These changes influence application validations, conformity assessment routes, UDI timelines, post-market responsibilities, and documentation standards. The new framework supports safer market access and a more predictable regulatory environment for local and global companies. The following sections explain the major updates and how they affect registration strategies for 2025 and 2026.
Key Changes in Malaysia’s 2025-2026 MDA Transition Pathway for Medical Device Registration
1. Full Online Product Classification (Effective 1 May 2025)
The MDA introduced an online-only method for product classification from 1 May 2025. Applicants submit classification requests digitally and receive classification letters through the same channel.
This change speeds up intake and improves document traceability. Every company must store the electronic classification letter because it serves as the foundation for MeDC@St registration.
Impact:
- Faster turnaround times
- No physical submissions
- Uniform processing standards
Action:
Ensure all product classification activities follow the digital intake format. Maintain a repository for classification letters to support audits and renewals.
2. Mandatory Import Permit Requirement (Enforced from 2 January 2026)
The import of medical devices will require a permit from 2 January 2026. MDA and Malaysian Customs are integrating import controls with the ePermit/DagangNet system.
Importers must complete account activation, user-role creation, and system training before enforcement begins. Delays in filing import permits may result in clearance issues at Customs.
Impact:
- More visibility across import operations
- Direct linkage between MDA approval and Customs verification
Action:
Activate the ePermit account, nominate Super Users and Sub-Users, and train your logistics team on permit submission. Submit import permits several days before shipment to prevent clearance delays.
3. MeDC@St Becomes the Central Platform for Registration
From 2025 onward, the MeDC@St platform remains the core system for all submissions. MDA has updated its guides and forms to standardise dossier structure for Class A, B, C, and D devices.
The updated guidance describes technical requirements for every conformity assessment route. It also clarifies expectations for verification submissions where the applicant uses foreign regulatory evidence.
Impact:
- Consistent dossier review
- Clear definition of documentary requirements
- Greater predictability in registration timelines
Action:
Review the latest MeDC@St submission guide and revise your internal templates. Confirm that your Authorized Representative maintains an active MeDC@St account and uses the newest file formats.
4. Expansion of Verification and Regulatory Reliance Pathways
MDA continues to strengthen pathways that allow faster approval for devices cleared by trusted foreign regulators. The verification pathway uses evidence from recognised authorities such as EU, Singapore HSA, or the US FDA, depending on MDA’s current acceptance list.
Eligible devices receive shorter review times because MDA focuses on confirming compliance rather than repeating full assessment.
Impact:
- Shorter time-to-market
- Lower documentary burden
- Predictable assessment steps
Action:
Check whether your device has approval from a regulator recognised by MDA. Confirm eligibility for the verification pathway before preparing a full CAB-based dossier. Align all certificate validity dates with the submission timeline.
5. Updated Administrative Rules for Lifecycle Management
MDA released updates relating to:
- Change notifications
- Re-registration timelines
- Evidence requirements for design or label modifications
- Manufacturing site additions
These updates provide clarity on how applicants should manage post-approval variations.
Impact:
- Stronger traceability of device lifecycle
- Predictable variation processing
- Better compliance alignment during audits
Action:
Update your change-control SOP. Maintain complete documentation for all post-market updates, including risk assessments and proof of regulatory impact analysis.
Compliance Checklist for 2025–2026 Malaysia Medical Device Registration
Requirement | Status | Recommended Action |
Online product classification | Active from May 2025 | Submit requests digitally and store e-classification letters |
Import permit | Mandatory from Jan 2026 | Activate ePermit account and train users |
MeDC@St submissions | Active | Follow new guide and templates |
Verification pathway | Expanded | Check eligibility through recognised authority list |
Lifecycle updates | Updated | Revise SOPs and internal review steps |
Practical Tips to Avoid Delays
- Maintain a digital archive of all classification letters and MeDC@St acknowledgements.
- File import permits at least one week before shipment.
- Align foreign regulatory certificates with MDA’s required format.
- Validate that labeling, UDI information (if applicable), and Instructions for Use match the Malaysian market.
- Check the status of conformity assessment bodies (CABs) to prevent selecting an outdated or inactive CAB.
Conclusion
Malaysia is refining it’s medical device regulatory system through structured digital processes, stronger import oversight, and a wider reliance ecosystem. Companies that adapt early will encounter fewer operational challenges and a faster review cycle.
Each 2025–2026 change targets predictability, auditability, and consistent regulatory outcomes. Manufacturers, importers, and ARs can achieve full compliance by updating SOPs, training teams, and aligning submission practices with the new MDA requirements.
How can DDReg help in Malaysia Medical Device Registration?
DDReg simplifies Malaysia medical device registration by aligning submissions with the 2025–2026 MDA transition pathway. Our team manages classification, MeDC@St dossiers, verification checks, and import-permit readiness to help manufacturers achieve fast, compliant market entry under the updated Malaysian requirements.
Read more from our experts: Transitioning from MDACS Listing to the Mandatory Medical Device Registration in Hong Kong