Regulatory Guidelines for Blood Collection Equipment in India
Mitra Industries is a premier provider of Transfusion Medicine & Blood Bank Solutions, ensures full compliance with India's stringent regulatory framework for Blood Collection Equipment. These guidelines, governed by the Drugs and Cosmetics Act 1940 and Medical Device Rules 2017, classify devices like Blood Collection Monitor Equipment as Class B (low-moderate risk), mandating CDSCO licenses for safety and efficacy. CDSCO Licensing Requirements Blood Collection Monitor and related equipment require MD-5 manufacturing licenses from State Licensing Authorities and MD-15 for imports from Central Licensing Authority. Blood Collection Machine Suppliers must submit Form MD-3 applications via the CDSCO SUGAM portal, including Device Master File (DMF), Plant Master File (PMF), ISO 13485 certification, risk management files, and test reports from NABL-accredited labs. Mitra Industries holds multiple certifications, facilitating seamless approvals for our high-precision Blood Co...