Malaysia refines requirements for labeling medical devices

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:

  1. Medical devices for home use must be labeled in Bahasa Malaysia. Other types of medical devices shall be labeled in English.
  2. 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.
  3. 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