New Labeling Guidelines for Devices in Malaysia

In February 2018, Malaysia’s Medical Device Authority released the Second Edition of the Guidance Documents on Requirements for Medical Device Labeling. Major changes include:

  1. The labels must include the contact details of the manufacturer and authorized representative;
  2. The labels must indicate the useful life of the device;
  3. The instructions for use (IFU) may not be needed or can be modified for low to middle risk devices;
  4. The final label should be affixed within 6 months of product approval.