Medical Devices and In Vitro Diagnostics Devices Guidelines

• Protocol for Performance Laboratory Evaluation of Hepatitis C Serology Assays, October, 2025 Download
• Protocol for Laboratory Performance Evaluation Of Hepatitis B Surface Antigen, October, 2025 Download
• Protocol for Performance Laboratory Evaluation of Combined HIV and SYPHILIS Serology Assays, October, 2025 Download
• Protocol for Performance Laboratory Evaluation of Malaria Plasmodium Falciparum (PF) and Malaria PF/Pan Antigen Rapid Diagnostic Tests, October, 2025 Download
• Protocol for Laboratory Performance Evaluation of Sars-Cov-2 Antigen Assays, March, 2025 Download
• Protocol for Performance Laboratory Evaluation of Human Immunideficiency Virus (HIV) Serology Assays, October, 2025 Download
• Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment, June, 2024 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 on Submission of Application for Change (S) to Approved Medical Devices and In-Vitro Diagnostics, June,2022 Download