NMRA approved Covid related products
Extension of validity period of Registration certificates & licenses upto 30th June 2021
Restriction for issuing Waiver of Registration (WORs) with effect from 26th June 2020
NMRA approvals to Face masks,PCR Test kits, PPE kits & Thermometers.
NMRA expedited review of COVID-19 diagnostic test kits in Sri Lanka
NMRA approvals relevant to DHS tenders
For information on the import & manufacture of Medicine, Surgical masks, Test kits, & Thermometers
Laboratory testing for COVID 19
Point-of-care immunodiagnostic tests for COVID 19
In response to the growing COVID-19 pandemic, multiple diagnostic test manufacturers have developed and begun marketing rapid and easy-to-use devices to facilitate testing for evidence of the infection. These simple test kits are based either on detection of proteins from the COVID-19 virus in respiratory samples (e.g. sputum, throat swab) or detection, in blood or serum, of human antibodies (e.g. IgG, IgM) generated in response to infection.
Therefore, based on current evidence, WHO recommends the use of these new point-of-care immunodiagnostic tests only in research settings. They should not be used in any other setting, including for clinical decision making and patient care, until evidence supporting use for specific indications is available. The NMRA does not issue market authorizations to point-of-care rapid antigen/antibody diagnostic test kits at present.
Molecular (e.g. PCR) testing of respiratory tract samples remains the recommended method for identification and laboratory confirmation of COVID-19 cases.