Malaysia Medical Device Import Permit Postponed to 1 July 2027

The Malaysia Medical Device Import Permit enforcement, originally scheduled for 2 January 2026, has been officially postponed to 1 July 2027. The decision primarily affects local distributors of medical devices in Malaysia, giving them additional time to comply with the new import permit requirements. Until the revised date, the importation of medical devices will continue under existing procedures for customs declaration purposes, ensuring business continuity for distributors and importers.

Key Details of the Postponement

• Original enforcement date: 2 January 2026

• New enforcement date: 1 July 2027

• Scope: Applies mainly to local distributors responsible for importing medical devices into Malaysia

• Current process: Until 1 July 2027, imports follow existing procedures for customs declaration

• Purpose: Allows distributors more time to comply with MDA import permit requirements

Voluntary Submission Window (Starting 1 June 2026)

To ensure a smooth transition, stakeholders may voluntarily submit Verification Slip applications for non-medical devices that fall under medical device tariff codes starting 1 June 2026. Applications are submitted via the online permit system (ePermit):

• ePermit Online Submission Portal

This voluntary period allows distributors to familiarise themselves with the online system and start the process ahead of mandatory enforcement.

Impact on Local Distributors

• Compliance readiness: Additional 18 months to prepare for import permit requirements.

• Operational continuity: Existing customs procedures remain valid until 1 July 2027.

• Planning advantage: Companies can schedule staff training, SOP updates, and internal audits in advance.

• Optional early adoption: Voluntary submission of Verification Slips allows early familiarity with the ePermit system.

Recommended Actions for Stakeholders

1. Review current medical device portfolios and verify which products require an import permit.

2. Familiarise with existing import procedures and maintain proper documentation for customs declarations.

3. Prepare for voluntary Verification Slip submissions starting 1 June 2026.

4. Update internal SOPs and train staff for the import permit process.

5. Monitor the MDA portal regularly for updates and guidance.

Internal Links  

• MDA Malaysia Medical Device Registration

External Links

• MDA official announcement on import permit postponement – Primary source for the revised enforcement date.

• MDA ePermit Online Submission Portal – For voluntary Verification Slip submissions starting 1 June 2026.

• Medical Device Authority (MDA) portal – Import Permit – Official portal for all updates and guidelines.

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