Medical Devices and In Vitro Diagnostics Devices Guidelines
Protocol For Performance Laboratory Evaluation Of Malaria Plasmodium Falciparum (PF) and MALARIA PF/PAN Antigen Rapid Diagnostic Tests, First Edition, April, 2024Download
Protocol for Performance Laboratory Evaluation of HIV SEROLOGY ASSAYS, First Edition, April, 2024Download
Protocol for Performance Laboratory Evaluation of Combined HIV and SYPHILIS SEROLOGY ASSAYS, First Edition, April, 2024Download
Protocol for Performance Laboratory Evaluation of HEPATITIS C SEROLOGY ASSAYS, First Edition, April, 2024Download
Protocol for Laboratory Performance Evaluation of HEPATITIS B Surface Antigen, First Edition, April, 2024Download
Protocol for Laboratory Performance Evaluation of SARS-CoV-2 Antigen Assays, First Edition, April, 2024Download
Guidelines for Conducting Performance Evaluation Oo In-Vitro Diagnostic Devices Submitted for Marketing Authorization, June, 2024Download
Guidelines on Good Review Practices for Regulation of Medical Devices, March, 2024Download
Guidelines for Notification of Medical Devices Exempted From Registration, First Edition, 2022Download
Guidelines on Submission of Application for Change (S) to Approved Medical Devices and In-Vitro Diagnostics, First Edition, 2022Download
Guidelines on Submission of Documentation for Registration of Medical Devices, April 2020Download
Guidelines on Submission of Documentation for Registration of In-Vitro Diagnostic Devices, April 2020Download
