The Medical Device Authority (MDA) of Malaysia has officially gazetted the Medical Device (Designated Medical Devices) Order 2026, introducing enhanced regulatory oversight for selected medical devices used in aesthetic and cosmetic treatments. The Order aims to strengthen patient safety, ensure device quality, and promote responsible use of medical technologies in Malaysia.
Read the full announcement:
https://portal.mda.gov.my/index.php/announcement/1738-kenyataan-media-pewartaan-perintah-peranti-perubatan-peranti-perubatan-yang-ditetapkan-2026
Purpose of the Medical Device (Designated Medical Devices) Order 2026
- To designate specific aesthetic and cosmetic medical devices as regulated medical devices in Malaysia.
- To strengthen the safety, quality, and performance oversight of aesthetic and cosmetic technologies.
- To ensure that only qualified and competent practitioners are permitted to operate these devices.
- To reinforce public health protections and regulatory accountability within the growing aesthetic sector.
Key Highlights
Designation of Selected Aesthetic and Cosmetic Devices
The Order identifies selected devices, such as laser systems, HIFU devices, and liposuction systems, as regulated medical devices. As a result:
- These devices must meet all regulatory requirements enforced by the MDA.
- Only compliant devices may be supplied, marketed, or used in Malaysia.
Usage Restricted to Qualified Practitioners
Operation of designated aesthetic and cosmetic devices is restricted exclusively to practitioners who are:
- Properly trained, and
- Recognised as qualified and competent by the relevant authorities.
Increased Regulatory Oversight
The aesthetic and cosmetic sector can expect:
- Strengthened oversight
- Enhanced market surveillance
- Stricter enforcement for non-compliant devices and operators
These measures aim to improve patient safety and ensure responsible device use.
Implications to Clients
Manufacturers, importers, distributors, and aesthetic service providers should:
- Review whether their products fall under the designated categories.
- Assess regulatory compliance status and prepare documentation as required by the MDA.
- Implement appropriate regulatory pathways early to maintain market access and operational continuity ahead of enforcement.
Proactive planning is recommended to avoid disruptions when the Order comes into effect.
Effective Date
1 June 2026
Stakeholders should prepare for full compliance by this date.
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.
