Malaysia fine-tunes medical device labeling requirements

Malaysia’s Medical Device Authority in October revised its requirements for the labeling of medical devices. Under the new guidelines, devices must be labeled with a Malaysian medical device registration number within six months from their date of registration. Medical devices for home use must be labeled in Bahasa Malaysia. Other types of medical devices must be labeled in English. Label contents must be submitted to the Medical Device Authority as part of the device registration process.

The revisions refine labeling requirements released one year ago, which mandated labels contain a series of identifying device characteristics, among them batch code, lot number or serial number, shelf life of the device in both unopened and opened states, optimal conditions for storage and date of manufacture.