Malaysia: MDA Bans Online Sales of Optical Devices and Contact Lenses

The Medical Device Authority (MDA) has released an official statement reinforcing a strict prohibition on the online sale of optical devices and contact lenses without proper authorization. These items are regulated under the Medical Device Act 2012 (Act 737) and must meet all registration and safety requirements before importation and sale in Malaysia.

Additionally, the Malaysian Optical Council (MOC), under the Optical Act 1991 (Act 469), mandates that only registered opticians and optometrists with valid permits may prescribe and supply these products. Online sales through social media or e-commerce platforms are explicitly banned to safeguard public health and uphold professional standards.

Why This Regulation Matters?

Optical devices and contact lenses are prescribed medical devices that require:

• A comprehensive eye examination

• Proper prescription issuance

• Dispensation by licensed professionals

Purchasing these products online without guidance may lead to improper usage, vision damage or infections, or eye health complications due to unverified prescriptions.

Key Online Sales Prohibitions

Under the Medical Device (Advertising) Regulations 2019, anyone advertising or selling unapproved medical devices (including contact lenses and optical appliances) online without MDA approval can face fines up to RM200,000, imprisonment up to two years, or both penalties.

Guidelines for Registered Practitioners Selling Online

MOC laid out comprehensive guidelines to regulate online selling activity. Only registered optometrists or opticians with a contact lens permit can sell optical products online, subject to strict conditions. Below are the highlights:

• Website Requirements

  • Must use local domain (.my) with local hosting and servers

  • Must be owned by a physical optical business with a registered optometrist and optician, with a contact lens permit, and registered with SSM

  • Optical product sales must be displayed on a dedicated webpage only

  • Only MDA-registered contact lenses may be displayed

    
    

• Sale Conditions

  • Only MDA-registered devices may be sold

  • Limited to retail (not wholesale) and top-up purchases

  • Customers must have valid prescriptions (issued within the last 6 months) and physically visit the clinic for examination

    
    

• General Terms

  • No social media links are allowed on the websites

  • Online marketplaces and e-commerce platforms are not permitted

    
    

Malaysia’s strict regulations on optical sales are designed to protect public eye health. While online sales are allowed under specific conditions, unauthorized e-commerce and social media sales are illegal. Consumers should always consult registered practitioners and avoid unverified online sellers to prevent vision risks.

You may refer to the full guidelines here: Guidelines for Online Sale of Optical Appliances and Contact Lenses

Source: Medical Device Authority (MDA)