The Medical Device Authority (MDA) has issued a Guidance Document to guide industry players and healthcare professionals on the control and management of obsolete and discontinued medical devices in Malaysia.

Medical devices that are obsolete or discontinued may face challenges in fulfilling mandatory registration requirements. In accordance with Section 5 of the Medical Device Act 2012 (Act 737), medical devices are required to be registered prior to being imported, exported, or placed on the market. To prevent disruption to healthcare services, the Minister has granted specific exemptions under the Medical Device (Exemption) Order 2024 for obsolete and discontinued medical devices, subject to appropriate controls.

In this regard, the Guidance Document was developed to assist establishments and healthcare professionals in understanding the applicable regulatory framework and in implementing appropriate control measures for obsolete and discontinued medical devices. The document outlines a structured approach to ensure that obsolete and discontinued medical devices continue to be managed in a manner that safeguards patient safety, maintains device performance, and supports continuity of healthcare services, while complying with the conditions of the exemption.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but 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