ORBIS Compliance

MDA Emphasizes Compliance for Optical Devices and Contact Lenses in Malaysia

Published /Malaysia

Reminder from the Medical Device Authority (MDA)

The Medical Device Authority (MDA) in Malaysia reminds the public that optical devices and contact lenses, whether corrective or not, must adhere to the definitions set forth in the Medical Devices Act 2012 (Act 737) and the Medical Devices Order (Declaration 2017), just like other medical devices. Only registered optical devices and contact lenses are permitted to be marketed to consumers. Furthermore, only Registered Optometry Practitioners, self-employed individuals, or optical businesses may sell optical devices and contact lenses online.

For more information, you can view the guidelines here: Guidelines for Online Sale of Optical Appliances and Contact Lenses - https://moc.moh.gov.my/wp-content/uploads/2021/08/GUIDELINES-FOR-ONLINE-SALE-OF-OPTICAL-APPLIANCES-AND-CONTACT-LENSES.pdf.

Continuous Monitoring

It is important to note that the MDA continuously monitors optical devices and contact lenses in the local market. The Authority has the authority to order the recall and suspend the distribution of optical devices and contact lenses on the market if any issues regarding the device's performance and safety arise. To ensure proper usage, users and the general public are advised to refer to the Manufacturer's instructions/manual.

Malaysia Quick Facts

Regulatory AgencyMalaysian Communications and Multimedia Commission (MCMC)
Certification TypeCompulsory
License Validity5 Years
Application LanguageEnglish
Legal License HolderRequired
In-country Testing RequirementDepending on the product

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