Mitra Industries
Our dedication to superior quality, honest practices, and lasting customer relationships drives every product at Mitra Industries
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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.
Why the Right Dialysis Machine Matters 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.
Key Standards and Compliance Devices must adhere to BIS IS 6710:2017 for single-use venous blood collection containers and Schedule F Part XII-B for blood bank operations, covering accommodation, staff qualifications, and equipment validation.
Application and Inspection Process Applicants pay ₹3,000-₹5,000 fees plus inspection charges; timelines span 3-6 months, involving site audits by drug inspectors and Notified Bodies. Post-licensing, annual renewals, reference sample retention (5 years), and adverse event reporting to CDSCO are required. Violations lead to suspension under Rule 122-O, emphasizing GMP and bio-medical waste disposal per 2016 Rules.
Mitra's Commitment to Compliance As trusted Blood Collection Machine Suppliers, Mitra Industries also offers high-quality Blood Transfusion Set solutions to ensure safe and efficient blood handling. With AI-monitored Blood Collection Monitor Equipment, we exceed regulatory benchmarks for accurate blood volume control. We support clients with licensing guidance, ensuring safe, quality products for India’s blood banks amid rising transfusion demands.
Contact us Website: mitraindustries.com
Tel: 01294099300
Address: 14/ 4, NH-19, Sector 31, Faridabad, Haryana 121003
