Recently, the Medical Device Authority (MDA) of Malaysia announced that the implementation of the Medical Device Import Permit system, originally scheduled to take effect on 2 January 2026, has been postponed to 1 July 2027.
Key Updates
- Implementation Date Postponed
The medical device import permit requirement, initially set to come into force on 2 January 2026, will now be implemented on 1 July 2027.
Prior to this date, medical devices may continue to be imported in accordance with the current regulatory procedures. - Transitional Arrangement
Starting from 1 June 2026, relevant stakeholders may voluntarily submit verification applications through the online ePermit system for products that are non-medical devices but fall under medical device tariff codes.
Original Announcement:
https://portal.mda.gov.my/index.php/ms/pengumuman/1726-update-on-the-enforcement-date-for-medical-device-import-permit
If you require assistance with medical device registration in Malaysia or related regulatory matters, please feel free to contact us.