On 1 December 2025, the Medical Device Authority (MDA) issued an important update regarding the enforcement timeline for the Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023.
The update provides:
- A revised enforcement date for the mandatory Import Permit requirement
- Continued application of existing import procedures during the transition period
- Introduction of a voluntary submission phase via the ePermit system
To read the full announcement: https://portal.mda.gov.my/index.php/announcement/1726-update-on-the-enforcement-date-for-medical-device-import-permit
Key Highlight on the Implementation Timeline
The mandatory enforcement of the Import Permit (IP) requirement has been postponed as follows:
- Original enforcement date: 2 January 2026
- Revised enforcement date: 1 July 2027
Until the new enforcement date takes effect, the importation of medical devices will continue to follow existing import procedures for customs declaration purposes.
Voluntary ePermit Submission Phase
To facilitate a smooth transition toward full implementation, MDA has introduced a voluntary submission phase:
- Effective from: 1 June 2026
- Stakeholders may voluntarily submit Verification Slip applications for non-medical devices that fall under medical device tariff codes via the online permit system (ePermit),
- Submissions will be made via the online ePermit system: https://newepermit.dagangnet.com
Stakeholders are encouraged to monitor the MDA portal regularly for updates and further guidance on Import Permit requirements.
Client Implications
Manufacturers, importers, and authorized representatives should take note of the following:
- The postponement from 2 January 2026 to 1 July 2027 provides an additional 18 months to:
- Prepare internal systems
- Align documentation processes
- Adjust operational workflows for Import Permit (IP) compliance
- Companies may begin early system familiarization through voluntary ePermit submissions starting June 2026.
Implementation Timeline for the ePermit System
MDA has confirmed the following phased implementation schedule:
- System Design & Development:
December 2023 – March 2025 (System under development) - Transition Period:
Starting 14 April 2025 (System goes live; importers begin transitioning) - Mandatory Phase:
Effective 1 July 2027 (ePermit system becomes fully mandatory)
Effective Date
The revised mandatory enforcement date for the Import Permit (IP) requirement is 1 July 2027.
Ongoing Public Guidance and Updates
All stakeholders are encouraged to visit the MDA portal regularly for official updates and further information on Import Permit requirements: https://portal.mda.gov.my/index.php/industry/import-permit/import-permit
For inquiries or support regarding the implementation of the Import Permit system and medical device import regulatory requirements in Malaysia, please contact sales@andamanmed.com for guidance.
