In November 2018, Malaysia’s Medical Device Authority released the Third Edition of its Guidance Documents on Requirements for Medical Device Labeling. Major changes include:
- Medical devices for home use must be labeled in Bahasa Malaysia. Other types of medical devices shall be labeled in English.
- Internationally recognized symbols and codes may be employed on labels. But if the meaning of a symbol is not obvious, is not understandable to the general user or has been newly introduced, an explanation must be provided.
- Labels must contain the following identifying characteristics of the device:
- Batch code, lot number or serial number
- Shelf life of the device in both unopened and opened states
- Optimal conditions for storage
- Date of manufacture