Malaysia Updates Exempt Device Requirements

The Malaysian Medical Device Authority (MDA) has updated the requirements for medical devices that are exempt from registration. The devices are the following:

  1. Demonstration models for marketing or education
  2. Models built for clinical research or performance evaluations
  3. Custom-made or special access devices

Devices falling into these categories must instead submit a notification to the MDA using designated forms for each category. Notifications are also required for situations such as clinical trial changes, adverse events, progress reports for investigational devices, or the export or disposal of medical devices after completion of clinical investigations