The Central Drugs Standers Control Organization vide its notification dated 22nd May 2020 has directed the manufacturer of medical devices including PPE coveralls to get themselves registered voluntarily on the CDSCO medical device online portal and to secure a registration number from CDSCO which shall be a benchmark for their quality management system.
Earlier PPE coveralls were not being manufactured in India, but due to Covid-19 situation a large number of domestic manufacturers have started producing PPE coveralls, therefore these PPEs need to be first registered under the new MD Rules, 2017 to be licensed by Central Drugs Standard Control Organisation (CDSCO) for manufacturing PPE kit as per basic manufacturing standards of ISO 13485 towards quality and safety.
Click here to read the Notification.
