On 25 March 2025, the Medical Device Authority (MDA) of Malaysia issued a press release announcing a prohibition on the online sale of optical devices and contact lenses. These products are designated as prescribed medical devices under the Medical Device Act 2012 (Act 737) and the Opticians Act 1991 (Act 469). Only registered opticians or optometrists are authorised to prescribe and dispense these devices.
Key Highlights
In its official directive, the MDA clearly states that:
- The sale of optical devices and contact lenses through e-commerce platforms or any form of online medium is strictly prohibited.
- The MDA does not grant approvals of any advertisements or promotions involving the online sale of these products.
- Legal enforcement will be applied against individuals or organisations found in breach of this regulation, including those facilitating online sales through digital platforms.
The policy is aligned with established standards to safeguard public health and ensure that prescribed medical devices are dispensed only by qualified professionals.
Enforcement and Reporting
The MDA encourages public vigilance and urges individuals to report any instances of online sales involving optical devices or contact lenses. Reports can be submitted via:
- MDA’s Feedback Management System (FEMES): https://femes.mda.gov.my
- Email: mdb@mda.gov.my
Implications to Clients
Entities found to be non-compliant may be subject to enforcement action. Penalties include fines up to RM200,000, imprisonment for up to two years, or both.
Effectivity Date: 25th March 2025
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