Medical Device Industry Alert

MDA Strengthens Collaboration with E-Commerce Platforms to Combat the Sale of Unregistered Medical Devices

The Medical Device Authority (MDA) has announced strengthened collaboration with TikTok Shop Malaysia, Shopee Malaysia, and Lazada Malaysia to curb the online sale and advertisement of unregistered medical devices.

This initiative reinforces MDA’s commitment to ensuring that only registered medical devices that comply with Malaysia’s regulatory requirements are marketed and sold through online platforms.

Key highlights from the press release:

• Enhanced content monitoring and product listing screening
• Stronger enforcement against non-compliant sellers
• Greater collaboration with e-commerce platforms
• Increased education and awareness programmes for consumers and sellers

MDA also reminds all companies and individuals involved in the importation, distribution, sale, and advertisement of medical devices to comply with the Medical Device Act 2012 (Act 737) and its subsidiary legislation.

Failure to comply may result in:

• Enforcement action by MDA
• Fines of up to RM200,000 and/or imprisonment for offences relating to unregistered medical devices
• Fines of up to RM300,000 and/or imprisonment for offences involving advertisements of unregistered medical devices, false or misleading claims, or advertisements without prior MDA approval

As industry stakeholders, let us continue to uphold regulatory compliance, safeguard patient safety, and foster responsible business practices across all sales channels.

We encourage all medical device manufacturers, importers, distributors, retailers, and online sellers to read the full MDA press release and ensure your products and advertisements comply with all applicable regulatory requirements.

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