The Medical Device Authority (MDA) of Malaysia has issued a media statement reminding all stakeholders of their responsibilities concerning the online sale, advertising, and distribution of medical devices under the Medical Devices Act 2012 (Act 737).
To read the full announcement: MDA Reminder on Registered Medical Devices [link]
Key Updates
1. Requirement for Registration and Licensed Supply
As stated in the MDA media statement:
- All medical devices sold in Malaysia must be registered with the MDA.
- Devices must only be supplied by licensed establishments in compliance with Act 737.
- MDA has noted a growing trend of unregistered devices being sold on e-commerce platforms by sellers without valid licenses or verifiable identities.
The MDA reiterates that unregistered devices pose significant health and safety risks, as they may not meet the required standards of quality, safety, and performance.
2. Responsibilities of Manufacturers and Distributors
According to the announcement, manufacturers and distributors must:
- Ensure their products are not supplied to unlicensed online sellers.
- Verify that all advertising and promotional materials, including those posted on e-commerce platforms, display the MDA registration number.
- Comply with all advertising requirements prescribed by the MDA.
3. Upcoming Inspections in 2026
Beginning in 2026, the MDA will conduct inspections across:
- Public and private healthcare facilities
- Universities
- Pharmacies
These inspections are intended to verify that only registered medical devices are being used.
Non-compliance may result in:
- Fines
- Product recalls
- Enforcement or legal action
Implications to Clients
- Ensure all medical devices distributed or sold in Malaysia are duly registered with the MDA and remain valid at the time of sale.
- Verify that partners and distributors — particularly those selling on e-commerce platforms — hold a valid MDA establishment license.
- Monitor distribution channels closely to ensure registered products are not supplied to unlicensed or unidentified online sellers.
Effective Date
Immediate, with inspections commencing in 2026.
For further clarification or assistance in meeting MDA requirements for online sales, registration, or advertising compliance, please contact sales@andamanmed.com or connect with our team.
