On 3 June 2025, the Medical Device Authority (MDA) issued a media statement highlighting its ongoing efforts to ensure that online advertisements of medical devices comply with regulatory requirements under the Medical Device Act 2012 (Act 737). The objective is to safeguard public health and safety by preventing the sale and advertisement of unregistered medical devices.
To read more, refer to the official media statement from MDA:
Online Advertisement Monitoring by MDA – Year 2024 (3 June 2025)
Effectivity
Monitoring and enforcement activities are ongoing, based on findings from 2024 and released publicly on June 3, 2025.
Key Highlights
Stakeholders may experience temporary relief from the increased regulatory fees under AO No. 2024-0016.
Proactive Online Monitoring
MDA, through its Monitoring Unit, conducted surveillance across various e-commerce and social media platforms, including:
- Shopee
- Lazada
- TikTok
- GrabMart
Findings from 2024
- 65% of medical device advertisements found online involved unregistered products.
- Most commonly advertised unregistered devices include:
- Contact lenses
- Condoms
- Oximeters
- Blood pressure monitors
- Acne patches
Enforcement & Collaboration
MDA is actively collaborating with other government agencies and platform operators to curb the spread of unregistered medical device advertisements.
Regulatory Action
- MDA will take strict enforcement action against individuals or entities advertising unregistered medical devices.
- This includes fines and other legal consequences under Act 737.
Advice to the Public
- Always verify that medical devices sold online are registered with MDA.
- Use MDA’s official search portal: https://mdar.mda.gov.my
Reporting Mechanism
- The public is encouraged to report suspicious or non-compliant advertisements through MDA’s Feedback Management System (FEMES): https://femes.mda.gov.my
Implications to Clients
Clients involved in the online sale, distribution, or promotion of medical devices must ensure that only registered products are advertised to the public. Failure to comply with MDA regulations may result in enforcement actions, including penalties and prosecution under Act 737.
For more information or assistance, contact us at sales@andamanmed.com or click the button below.
