CDSCO License for Paediatric blood donor set
Medical Device Information
Intended Use
A sterile assembly consisting of multiple collection containers (typically five connected flexible bags) of smaller volume than those used in adult sets. It is used for the storage of adult donor blood which is decanted from a normal adult size pack into this device in order to create smaller paediatric volume packs for infusion. The individual paediatric packs are then separated and sealed for later infusion. This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Paediatric Blood Donor Set (Class B Medical Device)
Introduction: Understanding the Paediatric Blood Donor Set and Its Regulatory Importance
The paediatric blood donor set is a critical single-use medical device designed for pediatric and neonatology care. It is a sterile assembly comprising multiple smaller collection containers connected to accommodate smaller blood volume packs derived from adult donor blood. These smaller pediatric packs facilitate safer and more precise blood transfusions for children, enhancing clinical outcomes.
Given the device’s vital role in pediatric transfusion medicine and its classification as a Class B medical device under Indian regulations, obtaining the correct CDSCO license is mandatory for manufacturers and importers. Compliance ensures patient safety, market access, and legal operation within India.
CDSCO Regulatory Framework for Paediatric Blood Donor Set
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. The paediatric blood donor set falls under Class B as per the CDSCO classification system, which considers the risk associated with the device’s intended use. The CDSCO framework mandates a manufacturing license (MD5) for Class A and B devices and an import license (MD15) for imported devices.
Regulatory compliance involves adherence to the Medical Device Rules, 2017, along with submission of detailed documentation, product testing, and inspections. The device was officially notified under File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021, which reinforces its regulatory status.
Risk Classification and License Requirements for Paediatric Blood Donor Set
- Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License (for Indian manufacturers)
- Authority: State Licensing Authority
Class B devices like the paediatric blood donor set require a manufacturing license under Form MD3, followed by an audit and compliance verification by a notified body. This process verifies the device's safety, quality, and efficacy before market authorization.
For importers, an MD15 import license issued by the Central Licensing Authority is essential.
Manufacturing License Process for Paediatric Blood Donor Set (MD5)
The process for obtaining the MD5 license for Class B devices consists of several critical steps:
Test License Application (Form MD13): Apply for a preliminary test license to conduct product testing. This takes approximately 1.5 to 2 months.
Product Testing: Submit the device samples to CDSCO-approved government testing laboratories. Testing ensures compliance with Indian standards and safety norms. Refer to the list of testing laboratories for authorized labs.
Documentation Preparation: Compile all required technical and quality documents, including Device Master File, Plant Master File, and Risk Management File.
Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: Schedule and complete an audit by a notified body listed on the CDSCO website to verify compliance. You can check the list of notified bodies here.
Queries Resolution: Address any queries raised by the CDSCO or the notified body during the review.
License Grant: Upon satisfactory assessment, the State Licensing Authority issues the MD5 license.
Manufacturing License Documents Required
Manufacturers must prepare and submit a comprehensive dossier including:
- Company Constitution and incorporation documents
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing device specifications and manufacturing process (Device Master File guide)
- Plant Master File (PMF) describing manufacturing infrastructure (Plant Master File guide)
- Essential Principles Checklist ensuring compliance with safety and performance
- Risk Management File demonstrating risk assessment and mitigation (Risk Management)
- Product test reports from approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016
Preparing these documents with accuracy and completeness is vital to avoid delays.
Import License Process for Paediatric Blood Donor Set (MD15)
For importers, the MD15 license process is managed by the Central Licensing Authority and involves:
Document Preparation: Collect necessary documents including valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master and Plant Master Files, wholesale license, and company constitution.
License Application Submission: Apply online through the CDSCO MD Online Portal using Form MD14.
Queries Resolution: Address any clarifications sought by CDSCO.
License Issuance: Upon acceptance, the MD15 import license is granted.
Unlike the manufacturing license, no test license or product testing within India is mandatory prior to import license issuance, but compliance with all standards remains essential.
Import License Documents Required
- Valid foreign manufacturing license
- Free Sale Certificate from country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license for import
- Company constitution documents
Timeline and Processing Duration
| License Type | Approximate Duration | Process Highlights |
|---|---|---|
| MD5 Manufacturing License (Class B) | 3-4 months | Includes 1.5-2 months for test license and product testing, followed by application, audit, and licensing |
| MD15 Import License | 5-6 months | Documentation review, queries resolution, license grant |
Manufacturers should plan for potential delays, especially during audit scheduling and query resolution phases.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 License (Class B) | Rs 5,000 | Rs 500 |
| MD15 Import License (Class B) | $2,000 (approx Rs 1.5 Lakh) | $1,000 per product |
Additional costs include:
- Product testing fees charged by government-approved labs
- Audit fees payable to notified bodies
- Professional consulting fees if opting for expert assistance
Budgeting for these expenses upfront helps streamline the application process without unexpected financial hurdles.
Common Challenges and Solutions
Challenge: Delays in product testing due to limited lab capacity.
Solution: Submit samples early and confirm testing schedules with authorized labs. Maintain communication to track progress.
Challenge: Incomplete documentation causing audit failures.
Solution: Utilize detailed checklists and expert reviews to ensure all files are thorough and compliant.
Challenge: Query resolution prolonging license grant.
Solution: Prepare prompt and precise responses with supporting evidence. Engage with regulatory consultants for technical clarifications.
Challenge: Understanding evolving regulatory requirements.
Solution: Stay updated with CDSCO notifications and amendments. Our team offers continuous regulatory updates and training.
Expert Consultation and Support
With over 25 years of experience and having successfully guided 500+ medical device companies, we provide end-to-end CDSCO licensing support for paediatric blood donor sets. From document preparation, audit readiness, to query handling, our experts ensure a smooth, compliant, and timely approval process.
We also assist with:
- Device and Plant Master File creation
- Risk management implementation
- QMS system alignment with ISO 13485
- Coordination with notified bodies and testing laboratories
Partner with us to leverage our deep regulatory knowledge and practical insights.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm the paediatric blood donor set as Class B under CDSCO.
Gather Documentation: Begin compiling all required documents, prioritizing Device Master File and Plant Master File.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.
Schedule Testing: Coordinate with authorized government labs to conduct product evaluation.
Prepare for Audit: Engage a notified body early and ensure your manufacturing site and QMS are audit-ready.
Submit Manufacturing License Application: File Form MD3 online after successful testing and document readiness.
Respond to Queries Promptly: Maintain open communication lines with CDSCO and notified bodies for swift issue resolution.
By taking these actionable steps, manufacturers and importers can confidently navigate the CDSCO regulatory landscape and bring their paediatric blood donor sets to market efficiently and compliantly.
For detailed guidance, explore our comprehensive MD5 License Guide or contact our regulatory consultants today.
