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Showing posts with the label medical devices registration

Government Calls For Voluntary Registration With CDSCO For PPE Coverall Manufacturers

On May 22, 2020, CDSCO (Central Drugs Standard Control Organisation) issued an advisory for voluntary registration of Personal Protection Equipment (PPE) coveralls and the testing at recognized labs under the Ministry of Textiles for effective and rapid tackling of Covid-19. Thus, this advisory gives permissions to all domestic manufacturers for producing Personal Protective Equipment with support from the Textile Industries. At present, there are a total of 9 laboratories in India which are responsible for testing and certifying PPE kits for quality assurance. In some of the states, some cases have been detected where some of the unregistered manufacturers are using some below standard lamination on those PPE coveralls for resisting the blood penetration to meet WHO stipulated specification of 100 GSM thickness. This puts the safety of those using these coveralls at risk. WHO along with Union Health Ministry has given advisory in May 2020 for the proper regulation of th