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THE Ministry of Health (MOH) has issued 12 warning notices following an enforcement operation targeting the sale of contact lenses, underscoring mounting regulatory concerns over non-compliant medical devices in the retail market.
The raids, conducted on 16 March, involved inspections of 19 premises selling contact lenses at Bazaria Wangsa Maju in Kuala Lumpur.
Authorities identified multiple breaches under the Medical Device Act 2012 and its related regulations, including the sale of unregistered products and failure to comply with mandatory labelling requirements.
“Contact lenses and optical devices are regulated medical devices and are classified as prescribed medical devices.
“Therefore, their use requires a prescription as well as professional services from registered opticians or optometrists, in accordance with the provisions under the Optical Act 1991,” the statement issued by the ministry said.
The ministry stressed that contact lenses and optical devices are regulated medical devices, and their use requires a valid prescription as well as professional services from registered opticians or optometrists, in accordance with existing legal provisions.
In a firm stance, the ministry also reiterated that the sale of contact lenses and optical devices online on any e-commerce platform is strictly prohibited.
“The ministry views this issue seriously because purchasing without proper examination and professional advice can expose users to eye health risks, including infections, corneal damage and serious vision complications,” the statement added.
As part of its enforcement position, the Medical Device Authority has not granted any approval for the advertising or online sale of contact lenses and optical devices.
Violations may result in action under the Medical Devices (Advertising) Regulations 2019, including fines of up to RM200,000, imprisonment of up to two years, or both upon conviction.
The ministry said enforcement efforts will be intensified, with no compromise for those breaching the law, including online platform providers that facilitate illegal sales.
Members of the public are advised to verify the registration status of medical devices through the Medical Device Authority Register and to seek services only from registered optical practitioners.
Complaints regarding non-compliant medical device sales can be submitted via the Medical Device Authority’s Feedback Management System. - April 3, 2026