Malaysia: MDA Releases First Edition Guidance on Importation of Medical Device for Re-Export (IRE)

To provide clarity and streamline compliance with the Medical Device Act 2012 (Act 737), on the 13 March 2025, the Medical Device Authority (MDA) has released the first guidance document on the application for the exemption of medical devices for Importation for Re-Export (IRE).

This document aligns with the newly issued Medical Device (Exemption) 2024 and aims to support industry professionals and healthcare providers in adhering to regulatory requirements.

1. Purpose and Scope

• The document serves as a reference for stakeholders involved in the importation of medical devices under exemption status.

• It clarifies the specific requirements and processes for applying for such exemptions

• The exemption applies to medical devices that are imported for re-export, including those used for maintenance, testing, sterilization, packaging, and labeling

2. Application Process

• The document details the procedures and requirements for submitting exemption applications to the MDA

• The applicant must be a registered company, licensed establishment, or authorized forwarding agent

• Applications must be submitted at least 21 days before the intended importation date

• Once approved, an IRE approval letter is issued, valid for 12 months, permitting multiple shipments within that period

• Extensions can be requested at least 14 days before expiry, with a maximum extension of 6 months

3. Post-Importation Requirements

• Importers must maintain records and submit quarterly declarations to the MDA

• All imported medical devices must be re-exported before the IRE approval letter expires

• Any unused medical devices must be disposed of safely in compliance with Malaysian regulations

4. Conditions of IRE Approval

• The imported medical devices must not be placed on the Malaysian market

• The applicant must comply with any directives issued by the MDA

• Any misuse of the IRE approval could lead to revocation of the approval and getting fined.

For manufacturers, distributors, and healthcare professionals, understanding these exemptions is critical in ensuring smooth operations while maintaining compliance with Malaysian regulatory standards. Exemptions can facilitate innovation and research by allowing the importation of devices for evaluation purposes without the need for full regulatory approval.

Access the full guidance document here: First Edition Guidance Document MDA/GD/0068: Importation of Medical Device For Re-Export (IRE)

Source: Medical Device Authority (MDA)