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September 22, 2026October 12, 2026
CDSCO, Compliance Guides, Import Compliance, Medical Devices

CDSCO Licence for Blood Bags in India: Class C Registration, ISO 3826 and Process

A blood bag collects, stores and transfuses blood and its components, with an anticoagulant/preservative solution that keeps the blood viable. Because it is a sterile, blood-contacting device central to transfusion safety, CDSCO regulates the blood bag as a Class C device with the blood-bag standard, the anticoagulant solution and sterility behind the licence. This guide covers the full CDSCO pathway for blood bags under the Medical Devices Rules, 2017 — classification, licence route, ISO 3826, the documents, the fees and the timeline.

Is a CDSCO Licence for Blood Bags Mandatory in India?

Yes. A blood bag is a notified Class C medical device and cannot be manufactured, imported or sold in India without a CDSCO licence. Because it is Class C, a domestic manufacturer applies to the Central Licensing Authority in Form MD-7 for a Form MD-9 licence; an importer applies in Form MD-14 for a Form MD-15 import licence. Single, double, triple and quadruple bags with CPD/CPDA/SAGM solutions fall within the framework.

Risk Classification of Blood Bags

Every medical device in India is placed in one of four risk classes (A, B, C, D) under the First Schedule of the Medical Devices Rules, 2017. The class fixes the authority, the form, the fee, the audit route and the timeline.

Blood Bags are classified as Class C (moderate-to-high risk). A blood bag is a sterile blood-contacting device essential to transfusion safety, which places it in Class C (moderate-to-high risk) under the First Schedule. Where a device could fall in two classes the higher class applies, and an accessory is classified in its own right; always confirm against the current CDSCO classification list.

CDSCO Licence for Blood Bags: Which Licence You Need

To manufacture blood bags in India (Class C) — apply in Form MD-7 to the Central Licensing Authority (CDSCO headquarters); the licence is granted in Form MD-9. A CDSCO joint audit team inspects the manufacturing site before the licence is granted — site inspection is mandatory for Class C and D.
To import blood bags (any class) — the overseas manufacturer appoints an Indian Authorised Agent who files Form MD-14 with the Central Licensing Authority; the import licence is granted in Form MD-15.
Test licence — for a small quantity imported or made for testing, evaluation, demonstration or clinical investigation: Form MD-12 application, Form MD-13 licence.
Loan licence — using another licensee’s approved premises: Form MD-4 (Class A/B) or Form MD-8 (Class C/D) for a licence in Form MD-6 or MD-10.

Applicable Standards for Blood Bags

Blood bags are evaluated against the blood-bag standard plus sterility and the anticoagulant solution:

ISO 3826 — plastics collapsible containers for human blood and blood components.
IS 14805 — the Indian Standard for blood bags, where applicable.
Anticoagulant/preservative solution — CPD, CPDA-1 or SAGM composition per pharmacopoeial requirements.
ISO 10993 series — haemocompatibility and biological evaluation of the PVC/plasticiser.
ISO 11135 / 11137 — sterilisation validation.
Storage/shelf-life and closure-integrity data supporting component storage.

Documents Required for Blood Bags CDSCO Licensing

Whether you file for a manufacturing or an import licence, CDSCO expects the same core technical dossier built around the device:

Covering letter and application form — Form MD-3 / MD-7 (manufacture) or Form MD-14 (import) on the CDSCO Medical Device Online portal, stating every device, variant and site.
Device Master File (DMF) — device description and intended use, materials, design and manufacturing information, ISO 14971 risk file, verification/validation data, sterilisation validation where applicable, shelf-life/stability data and the Essential Principles checklist.
Plant Master File (PMF) — site layout, equipment, utilities/HVAC, organisation chart with competent technical staff and the QMS procedures governing production.
ISO 13485 QMS certificate — current, with a scope covering the device.
Essential Principles of Safety and Performance — a completed checklist mapping the device against each applicable principle with the standard/evidence relied on.
Risk management file (ISO 14971) — hazards, risk controls and residual-risk justification.
Test / performance reports — against the applicable BIS/IS or ISO/IEC standards from an accredited laboratory.
Labels, IFU and packaging — meeting the labelling requirements of the Medical Devices Rules (manufacturer, licence number, sterile status, single-use symbols).
Undertaking and declaration of conformity to the Essential Principles and applicable standards.
Government fee receipt — paid online through the CDSCO portal.

Device-specific documents on top of the core set for blood bags:

ISO 3826 / IS 14805 test reports — volume, seal/closure integrity, transparency and centrifugation performance.
Anticoagulant-solution specification and CoA against pharmacopoeial limits.
Haemocompatibility and plasticiser (DEHP) data per ISO 10993.
Sterilisation validation with the sterility assurance level.
Shelf-life / component-storage data supporting the labelled claims.
Country-of-origin approval and Free Sale Certificate for imports.

For an import licence (Form MD-14) there are three further essentials:

Free Sale Certificate (FSC) — from the National Regulatory Authority of the country of origin, legalised (apostille/embassy attestation).
Country-of-origin regulatory approval — US FDA 510(k)/PMA, EU CE certificate or equivalent.
Power of Attorney and Authorised Agent licence — notarised, legalised PoA to the Indian Authorised Agent, plus the agent’s valid wholesale/manufacturing licence.

QMS & Essential Principles — What CDSCO Checks

Essential Principles of Safety and Performance (Fifth Schedule) — the device must be safe and perform as intended, with risks reduced as far as possible; shown through recognised standards and the risk-management file.
Quality Management System (ISO 13485) — design controls, supplier control, process validation, traceability, complaint handling and CAPA, evidenced at audit.
Risk management (ISO 14971) — a living file with residual risks justified and communicated in the IFU.
Clinical evidence — proportionate to the class: clinical evaluation for lower-risk devices and clinical investigation data for many Class C/D and novel devices.

Label & IFU Requirements Specific to Blood Bags

Blood-bag labelling is checked for volume, anticoagulant and sterility:

Bag type (single/double/triple/quad), nominal volume and anticoagulant (CPD/CPDA/SAGM).
Manufacturer name and address, and the CDSCO licence number.
Batch/lot number, date of manufacture and use-by date.
“STERILE” with the sterilisation-method symbol and a single-use symbol.
Storage conditions and blood-component-storage information in the IFU.

Device and Solution: A Combined Product

A blood bag is really two things in one — the plastic container (device) and the anticoagulant/preservative solution (which is treated to pharmacopoeial standards). Both are assessed: the bag’s integrity and haemocompatibility, and the solution’s composition and CoA. Plasticiser (DEHP) content also draws attention on safety grounds. Register the specific bag configurations and solutions you supply, with evidence for both elements — a bag evidenced without its solution, or vice-versa, is an incomplete file.

Step-by-Step: CDSCO Registration Process

Confirm the classification. Fix the risk class against the CDSCO classification list and the First Schedule — Class C here — which decides the form, authority, fee and audit route.
Choose the route. Manufacture (Form MD-7 → MD-9) or import (Form MD-14 → MD-15). Importers appoint an Indian Authorised Agent holding a valid manufacturing or wholesale licence.
Build the Device Master File and Plant Master File. Assemble device description, materials, design and process data, the ISO 14971 risk file, sterilisation/stability data and the site file with the QMS.
Complete the Essential Principles checklist. Map the device against each applicable essential principle and cite the BIS/IS or ISO/IEC standard or test report relied on.
Draw the test and performance reports. Test to the applicable standards at an accredited laboratory; sterile and measuring devices carry additional validation.
Register and file on the CDSCO Medical Device Online portal. Create the account, pay the government fee online and upload the full dossier under the correct form.
Site audit / inspection. A CDSCO joint audit team inspects the manufacturing site before the licence is granted — site inspection is mandatory for Class C and D.
Respond to queries and receive the licence. Answer the deficiency letter within the stipulated period; on approval the licence issues in Form MD-9 (manufacture) or MD-15 (import).

Government Fees and Timeline

Fees are set in the Second Schedule of the Medical Devices Rules and paid online through the CDSCO portal. For manufacture of a Class C device the fee is Rs 50,000 per site plus Rs 1,000 for each distinct device, paid to the Central Licensing Authority (CDSCO headquarters). Import fees under Form MD-15 are charged per site and per device in USD — roughly USD 1,000 per site plus USD 50 per device for lower-risk devices, up to about USD 3,000 per site plus USD 1,500 per device for Class C and D. A test licence (Form MD-13) carries a modest fee. Always confirm the current figure on the CDSCO portal before filing.

A complete Class C manufacturing file is typically cleared in about six to nine months; an import (MD-15) file usually takes six to nine months. Every deficiency letter effectively restarts the clock. Unlike the old registration certificates, an MDR 2017 licence does not expire — it stays valid as long as the retention fee (equal to the licence fee) is paid every five years and the conditions of licence are met.

Common Mistakes That Trigger a CDSCO Query

Class C blood-contacting devices draw detailed queries. The recurring reasons are:

Closure/seal-integrity or centrifugation data missing.
Anticoagulant-solution CoA not against pharmacopoeial limits.
Haemocompatibility or plasticiser data absent.
Sterilisation validation not matching the actual cycle.
Free Sale Certificate scope not covering all configurations on import.

Related Approvals to Plan Alongside CDSCO

DGFT Importer-Exporter Code — mandatory for any importer of record before the first consignment.
Wholesale / sale licence (Form 20B/21B or Form MD-42) — for stocking and distributing the device; the Indian Authorised Agent for an import licence must already hold one.
Legal Metrology (LMPC) registration — importers of pre-packaged devices declare MRP, net quantity, importer details and country of origin on the pack.
BIS certification — where the device or its electrical components fall under a mandatory BIS/CRS scheme.

Post-Approval Obligations

Print the licence number on the label and keep the Essential Principles conformity current.
Operate a Post-Market Surveillance (PMS) system and file the Periodic Safety Update Report (PSUR) on the schedule for the device’s class.
Report adverse events and field safety corrective actions through the Materiovigilance Programme of India (MvPI) and to CDSCO within the prescribed timelines.
Report any change in device, materials, site, labelling or QMS, and any regulatory action or recall in another country.
Retain distribution records for traceability and allow CDSCO to draw samples and inspect the premises.
Pay the retention fee every five years to keep the licence in force, and track BIS/ISO standard revisions.

Frequently Asked Questions

What CDSCO class is a blood bag?

A blood bag is Class C, so a domestic manufacturer files Form MD-7 for an MD-9 licence with the Central Licensing Authority, and an importer files Form MD-14 for an MD-15 licence.

Which standard applies to blood bags in India?

ISO 3826 for collapsible blood containers and the Indian Standard IS 14805, with the anticoagulant solution to pharmacopoeial requirements and ISO 10993 haemocompatibility.

Is the anticoagulant solution assessed too?

Yes — the CPD/CPDA/SAGM solution’s composition and certificate of analysis against pharmacopoeial limits are part of the evidence, alongside the bag itself.

Is a site inspection required?

Yes — for Class C manufacture, a CDSCO joint audit team inspects the site before the MD-9 licence is granted.

How long does blood-bag registration take?

Budget roughly six to nine months for a complete Class C manufacturing (MD-9) or import (MD-15) file.

Does the licence expire?

No — the MDR 2017 licence is perpetual, subject to the five-yearly retention fee and continued compliance.

Why Choose PCN India Global

Classification triage — we confirm the correct risk class for your blood bags against the current CDSCO list before anything is drafted.
Route selection — manufacture (MD-5/MD-9) or import (MD-15), with the Indian Authorised Agent arrangement handled.
Dossier build — Device Master File, Plant Master File, Essential Principles checklist and ISO 13485/ISO 14971 readiness.
Standards and testing — the right BIS/IS or ISO/IEC standards mapped and accredited test reports coordinated.
End-to-end online filing — application, audit support, query response and the licence grant managed for you.
Adjacent approvals — DGFT/IEC, LMPC, wholesale/sale licence and BIS coordinated alongside your CDSCO licence.

PCN India Global manages the complete CDSCO process for blood bags — from classification and route selection to Device and Plant Master File preparation, online filing, audit support and the licence grant. WhatsApp or call +91 80109 05029, or email admin@pcnindiaglobal.com, to get your registration underway.

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