Regulatory Background

MDA has gazetted officially the Medical Device (Designated Medical Device) Order 2026. The Order 2026 will take effect on 1 June 2026. The objective of the Order 2026 is to enhance regulatory oversight in Malaysia, thereby strengthening patient safety, improving quality assurance, and ensuring appropriate use within the Malaysian healthcare landscape.

 

Scope of Designated Medical Devices

The Order designates devices that include certain technologies mainly used in aesthetic, therapeutic, and clinical settings such as medical lasers, High-Intensity Focused Ultrasound (HIFU) systems, and liposuction devices. These devices are subjected to meet Malaysian regulatory requirements for quality, safety, and performance before they can be supplied, marketed or used in Malaysia.

 

Implementation and Industry Engagement

Through this Order, the use of medical devices in aesthetic and beauty treatments will be comprehensively regulated. This gazettement provides significant benefits to the public by protecting users from unregulated devices that may not meet safety standards. MDA will work collaboratively with industry stakeholders, healthcare professionals and all relevant parties to ensure a smooth implementation ahead of the effective date.

With the upcoming implementation of the Medical Device (Designated Medical Devices) Order 2026, companies supplying aesthetic and therapeutic devices in Malaysia should assess whether their products fall within the designated scope and ensure compliance with applicable regulatory requirements.

Qualtech supports medical device manufacturers in evaluating product classification, preparing regulatory submissions, and aligning with MDA requirements ahead of the effective date.

Contact us to ensure your Malaysian market access strategy remains compliant and well-prepared.

 

Reference:

Gazettement of the Medical Device Order 2026