Malaysia: MDA Implements Medical Device Import Permit Requirement (transition w.e.f 14 April 2025)

In a move to enhance the regulation and traceability of medical device imports, the Medical Device Authority (MDA) has officially implemented a new requirement which is importers must now obtain an Import Permit (IP) for all incoming medical devices, as stipulated in the Customs (Prohibition of Import) Order 2023.

As the designated Other Government Agency (OGA), MDA enforces this regulation to ensure that all imported medical devices meet national safety, quality, and performance standards before entering the Malaysian market.

Key Measures Implemented

a. Tariff Code Classification

Medical device tariff codes are now formally included in the Customs (Prohibition of Import) Order 2023 to streamline classification

b. Launch of the ePermit System

A new online platform has been developed to facilitate import permit applications for medical devices and verification slips applications for non-medical devices that fall under similar tariff codes

c. Guidelines and User Manual

Detailed support materials have been prepared to assist stakeholders with navigating the import permit application process effectively

Import Permit Application Procedure

• The application must be submitted online via the ePermit System

• Submit your application at least 7 days before your planned shipment

• MDA will process applications within 3 working days from the date of submission

• For urgent shipments (e.g., overnight land shipments from Singapore/Thailand or temperature-sensitive goods), expedited processing may be offered within 24 hours, subject to payment confirmation

Credit: MDA

Industry Awareness Sessions & Hands-On Training

To support a smooth transition and ensure industry-wide compliance, MDA is organizing a series of awareness sessions and hands-on training workshops. These sessions are designed to provide clarity on the new import permit process, demonstrate the use of the ePermit system, and address common queries from importers and distributors. These sessions are highly recommended for manufacturers, importers, distributors, and logistics providers involved in the MedTech supply chain.

You can view the full training and session schedule here.

The introduction of the import permit requirement marks a critical step in strengthening Malaysia’s medical device regulatory framework. It helps ensure product integrity, traceability, and public health protection. Failure to comply may result in delays, penalties, or the denial of importation of goods. Stakeholders are required to familiarize themselves with the updated ePermit process and register for a training session to ensure full understanding and compliance.

As the MedTech industry continues to evolve, regulations like this help uphold international standards and improve public confidence in imported healthcare technologies.

Staying informed with ARQon and prepared will ensure your business remains efficient, compliant, and ready for growth.

Source: Medical Device Authority (MDA)