Medical Devices and In Vitro Diagnostics Devices Guidelines

  • Guidelines on Submission of Documentation for Registration of Medical Devices, April 2020 Download
  • Guidelines on Submission of Documentation for Registration of In-Vitro Diagnostic Devices, April 2020 Download
  • Guidelines for Notification of Medical Devices Exempted from Registration, June 2022 Download
  • Guidelines on Submission of Application for Change(s) to Approved Medical Devices and In-Vitro Diagnostics, June 2022 Download