Regulatory Guidelines for Blood Collection Equipment in India

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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 Collection Monitor Equipment.

 

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. Technical staff includes MD Pathologists or MBBS with transfusion medicine diplomas; Mitra employs qualified experts for phlebotomy and monitoring. Testing for HIV, Hepatitis B/C, and syphilis is mandatory, with SOPs for donor screening and equipment sterilization.

 


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.

 

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