Malaysia Strengthens Regulation of Medical Devices Used for Aesthetic and Cosmetic Purposes

On January 9, 2026, the Malaysian Medical Device Authority (MDA) issued the Medical Device (Prescribed Medical Device) Order 2026, aimed at strengthening the regulation of medical devices used for aesthetic and cosmetic purposes to ensure consumer safety and protection. The regulation is scheduled to come into effect on June 1, 2026.

The regulated devices include:

• Laser treatment devices
• High-Intensity Focused Ultrasound (HIFU) devices
• Liposuction devices
• Other related devices

These devices should comply with relevant regulatory requirements to ensure that operators possess government-recognized qualifications and skills, thereby guaranteeing the safety, quality, and suitability of the devices when used on the general public. This initiative also reflects the government’s commitment to safeguarding public health and ensuring that the aesthetic and cosmetic industry develops in a sustainable, ethical, and legally compliant manner.

Our Services

• Malaysia Cosmetic Notification
• Malaysia Local Company Authorization & License Holding Services
• Preparation and Compilation of Product Information File (PIF)
• Electronic Account Registration
• Formula and Packaging Review
• Product Testing Services
• Logistics and Customs Clearance

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information:
Malaysia MDA