CDSCO issues advisory regarding voluntary registration of PPE Coveralls

Jun 02, 2020 | by Avantis RegTech Legal Research Team

Industry Specific Compliance

The Central Drugs Standard Control Organisation (CDSCO) on May 22, 2020 has issued advisory regarding voluntary registration of Personal Protection Equipment (PPE) Coveralls and testing at labs recognised by the Ministry of Textiles to tackle Covid-19. The domestic manufacturers are hereby requested to produce Personal Protective Equipment (PPE) with support of Textile industries. The Coveralls must pass the test prescribed by Ministry of Health and Ministry of Textiles. It is important to note that Order No. SO 648(E) dated February 11, 2020 had specified the definition of ‘medical devices’ under Drugs and Cosmetics Act along with its regulations including the voluntary registration scheme for PPE Coverall.

The PPE Coveralls Manufacturers may also register themselves at online portal to secure a registration number from CDSCO which will be a benchmark for their quality management system.

[Notice No. DGCI/Misc/2020(119)]


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