Medical Devices and In Vitro Diagnostics Devices Guidelines

• Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment Download
• Guidelines for Conducting Performance Evaluation Oo In-Vitro Diagnostic Devices Submitted for Marketing Authorization, June, 2024 Download
• Guidelines on Good Review Practices for Regulation of Medical Devices, March, 2024 Download
• Guidelines for Notification of Medical Devices Exempted From Registration, First Edition, 2022 Download
• Guidelines on Submission of Application for Change (S) to Approved Medical Devices and In-Vitro Diagnostics, First Edition, 2022 Download
• 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