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