Suspension and Cancellation of Establishment Licence and Medical Device Registration Requirements
All establishments placing medical devices in the market must maintain a valid Establishment Licence and registered medical devices as required under the Medical Device Act 2012 (Act 737). The public may verify establishment licence status and device registration through the Malaysian Medical Device Registry (MMDR).
Manufacturers and sponsors placing medical devices on the Malaysia market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗