On 26 March 2025, the Medical Device Authority (MDA) of Malaysia officially announced the implementation of a Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023. This new regulation mandates that importers obtain an Import Permit for bringing medical devices into Malaysia. The MDA has been designated as the responsible Other Government Agency (OGA) to issue these permits.
Key Highlights
Importers must submit their applications via the ePermit System at least seven (7) days prior to shipment. The standard processing time is three (3) working days, although a 24-hour expedited process is available for urgent shipments, such as overnight deliveries from Singapore or Thailand, or for temperature-sensitive items.
Application Process
- Step 1: Compliance with Medical Device Act 2012 (Act 737) – Obtain Registration Certificate of Exemption Letter
- Step 2: Apply for Import Permit via ePermit System
- Register as an importer, exporter, or agent.
- Submit the application for verification & approval.
- RMCD acknowledges and issues Import Permit or Verification Slip.
- Step 3: Custom Declaration via SMK System – Import goods via Sea, Land or Air.
Associated Fees
- Import Permit Fee: RM130 per application (except for samples intended for investigation).
- Verification Slip Fee: RM50 per application.
- Processing Fee Waiver: A waiver of up to RM130 is applicable for nine (9) months, although registration and annual subscription fees for the ePermit system still apply.
Industry Support Measures
To facilitate compliance, the MDA will roll out a series of engagement activities:
- Briefing Sessions: Scheduled for April 2025
- Hands-on Training: To be conducted from May to August 2025, focusing on system navigation and application procedures.
Effective Date
- System Development: December 2023 – March 2025
- Transition Period: Commences 14 April 2025 (voluntary adoption begins)
- Mandatory Compliance Date: 2 January 2026
Implications to Clients
All medical device importers are urged to register their Super Users and Sub-Users and familiarize themselves with the Import Permit application process. Failure to comply with the Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023 may result in legal and financial penalties.
References
- Guidelines: The Guidelines for Applying for a Medical Device Import Permit under the Customs (Prohibition on Imports) Order 2023 are currently in draft.
- User Manual: The ePermit System User Manual is currently in draft.
- List of HS Codes: The identified HS codes that may be included in the gazettement are available in:
https://drive.google.com/file/d/1-QgQWZ-NBfRXpZhmV_6qxh9wP1OTt8GT/view
Refer to the MDA’s announcement here:
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