The Ministry of Health and Family Welfare (MoH&FW) on April 26, 2023, issued a notification to amend notification no. S.O. 2237(E) dated June 01, 2018, regarding the facilities for carrying out tests and evaluation of medical devices.
The following amendment has been stated:
• In the Table, for serial number (1) and the entries relating thereto, the following has been substituted, namely: —
“1 The National Institute of Biologicals, Noida
In-Vitro Diagnostics Medical Devices for Human Immunodeficiency Virus, Hepatitis B Surface Antigen, Hepatitis C Virus, Syphilis, Blood Grouping, RT-PCR Kits for Diagnosis of Covid-19, Ribonucleic acid (RNA) Extraction Kits for Diagnosis of Covid-19, Viral Transport Medium (VTM) for Diagnosis of Covid-19, RTLAMP Kit for diagnosis of Covid-19, Glucose Test Strip and Fully Automated Analyser Based Glucose Reagent and Glucometer.”
[Notification No. S.O. 1928(E)]
