Malaysia Gazettes New Controls for Aesthetic Medical Devices Effective June 2026

Cyberjaya, January 2026, Malaysia has taken a significant step toward strengthening patient safety in the aesthetic and beauty sector. The Medical Device Authority (MDA) has officially gazetted the Medical Device (Prescribed Medical Devices) Order 2026, which will come into force on 1 June 2026.

This new order expands regulatory oversight over specific medical devices commonly used in aesthetic and cosmetic treatments, reinforcing Malaysia’s commitment to safe, ethical, and well-regulated medical practices.

What Does the New Order Cover?

Under the gazetted order, several medical devices used in aesthetic and beauty procedures will now fall under stricter regulatory control. These include, but are not limited to:

• Laser treatment devices

• High-Intensity Focused Ultrasound (HIFU) devices

• Liposuction devices

• Other related aesthetic medical devices

  
  

These devices will now be subject to defined regulatory requirements to ensure they are used appropriately, safely, and by qualified personnel.

Why This Matters

The growing popularity of aesthetic treatments has increased the need for stronger safeguards. Many of these procedures involve advanced medical devices that carry potential risks if misused or operated by unqualified individuals.

With this new order, MDA aims to:

• Protect consumers from unsafe or non-compliant aesthetic treatments

• Ensure operators are properly trained and qualified, as recognised by the government

• Maintain quality and safety standards for medical devices used on the public

• Support the responsible growth of the aesthetic and beauty industry in Malaysia

This move enhances public confidence by ensuring treatments are delivered responsibly and in line with national safety standards.

Impact on the Aesthetic & Beauty Industry

For industry players, this gazettement signals the need for early preparation. Clinics, practitioners, and businesses offering aesthetic services should begin reviewing:

• Device compliance status

• Operator qualifications and training

• Internal procedures aligned with MDA requirements

While the enforcement date is set for June 2026, proactive compliance will be key to a smooth transition.

Looking Ahead

MDA has confirmed that it will continue engaging with stakeholders, including practitioners, industry operators, and the public, to support effective implementation of the order before it comes into force.

This regulatory development reflects Malaysia’s broader commitment to public health, patient safety, and sustainable industry growth while allowing innovation to continue within a well-controlled framework.