The Medical Device Authority (MDA) wishes to inform all industry players and healthcare providers on the publication of the Guidance Document on Import and/or Supply of Unregistered Medical Devices under Special Access Exemption Application.

This guidance document outlines the regulatory framework governing the importation and use of unregistered medical devices under the Special Access Exemption, as stipulated under the Medical Device (Exemption) Order 2024. It clarifies the eligibility of personnel authorised to apply for such exemptions, specifies the procedures for notification to the Authority, and details the responsibilities of applicants in the management and use of unregistered medical devices.

The guidance further emphasises that an application for exemption shall be obtained prior to the importation and/or supply of the medical devices. This mechanism is intended to facilitate timely access to medical devices for specific needs in healthcare settings, while ensuring regulatory oversight and patient safety are maintained.

This guidance document shall be read in conjunction with the current laws and regulations applicable in Malaysia, which include but are not limited to the following:
a) Medical Device Act 2012 (Act 737);
b) Medical Device Regulations 2012;
c) Medical Device (Exemption) Order 2024.

To view the guidance document, CLICK HERE.