CDSCO License for Blood photochemical treatment agent
Medical Device Information
Intended Use
A sterile photochemical agent (psoralen) intended to be used in conjunction with ultraviolet A (UVA) irradiation to eliminate nucleated cells from blood or blood components (e.g. plasma, leukocyte-enriched blood fraction).
Comprehensive Guide to CDSCO Licensing for Blood Photochemical Treatment Agents (Class C Medical Devices)
As specialists with over 25 years of experience assisting more than 500 medical device companies, we understand the intricacies of securing CDSCO licenses for complex, high-risk devices like the Blood Photochemical Treatment Agent. This sterile photochemical agent, used alongside UVA irradiation to eliminate nucleated cells in blood components, falls under Class C in the oncology category. Navigating the CDSCO regulatory framework effectively is crucial to ensuring timely market access in India.
CDSCO Regulatory Framework for Blood Photochemical Treatment Agents
Blood Photochemical Treatment Agents, classified as Class C devices under the CDSCO classification system, are considered moderate-to-high risk due to their critical clinical application in oncology and blood safety. The Central Drugs Standard Control Organisation (CDSCO) regulates these devices to ensure safety, efficacy, and quality compliance before they enter the Indian market.
Manufacturers of Class C devices must obtain the MD9 Manufacturing License, which is issued by the Central Licensing Authority. Importers require the MD15 Import License from the same authority.
Risk Classification and License Requirements
- Device Name: Blood Photochemical Treatment Agent
- Risk Class: Class C (Moderate-to-High Risk)
- Regulatory Pathway: MD9 Manufacturing License (Form MD7)
- Applicable Authority: CDSCO Central Licensing Authority
- Notification Reference: File No. 29/Misc./03/2020-DC (153) — Part 1
- Notification Date: 11.10.2022
This classification mandates stringent requirements including product testing, comprehensive documentation, and a rigorous audit process.
Manufacturing License Process for Class C Devices (MD9 License)
The MD9 license process for Class C devices typically spans 4 to 5 months and involves the following key steps:
- Test License Application (Form MD13): Initial application for a test license, which takes approximately 1.5 to 2 months to be granted.
- Product Testing: Conducted at CDSCO-approved laboratories to validate safety and performance. Refer to the list of testing laboratories for approved facilities.
- Document Preparation: Compilation of technical files, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- License Application (Form MD7): Submission of the manufacturing license application through the CDSCO MD Online Portal.
- CDSCO Inspection and Audit: A thorough inspection by CDSCO officials evaluating the manufacturing facility, quality management system, and compliance.
- Resolution of Queries: Addressing any observations or deficiencies raised during inspection.
- Grant of License (Form MD9): Upon successful completion, the manufacturing license is issued.
Manufacturing License Documents Required for Blood Photochemical Treatment Agents
To ensure a seamless application process, prepare the following documents meticulously:
- Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement for manufacturing premises
- Technical Staff Qualification and Experience Certificates
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design, composition, and performance data. Our detailed Device Master File guide can assist in preparation.
- Plant Master File (PMF) describing facility layout, equipment, and manufacturing processes. See our Plant Master File guide for best practices.
- Essential Principles Checklist ensuring compliance with CDSCO guidelines
- Risk Management File documenting hazard analysis, risk control measures, and benefit-risk assessment. Visit our Risk Management guide for comprehensive insights.
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) compliant with CDSCO and Indian language requirements
- Quality Management System (QMS) Documents aligned with ISO 13485:2016 standards
Import License Process for Blood Photochemical Treatment Agents (MD15 License)
If you are importing the Blood Photochemical Treatment Agent, you must secure the MD15 Import License from CDSCO Central Licensing Authority. Key aspects include:
- No test license required prior to application
- Application submitted on Form MD14 via the CDSCO MD Online Portal
- Document review, query resolution, and license issuance typically take 5 to 6 months
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate or Equivalent
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License in India
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Approximate Duration | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Application, product testing setup |
| Manufacturing License (MD9) | 4 – 5 months | Document review, audit, query resolution |
| Import License (MD15) | 5 – 6 months | Document verification, license grant |
Government Fees and Costs
| License Type | Application Fee (INR) | Per Product Fee (INR) | Notes |
|---|---|---|---|
| MD9 (Class C) | 50,000 | 1,000 | Includes audit and testing fees |
| MD15 (Import) | $3,000 per site | $1,500 per product | Paid in USD, varies by class |
Note: Fees are subject to revision by CDSCO. Plan your budget accordingly.
Common Challenges and Solutions
- Complex Documentation: Many applicants struggle with compiling comprehensive Device and Plant Master Files. Engage experienced consultants or refer to detailed guides to avoid rejections.
- Testing Delays: Testing at government-approved laboratories can be time-consuming due to high demand. Initiate test license and sample submissions early.
- Audit Non-Compliance: Insufficient preparation for CDSCO inspections leads to repeated queries. Conduct internal audits and mock inspections.
- Query Resolution: Delayed responses to CDSCO queries prolong the timeline. Assign dedicated personnel for prompt communication.
Expert Consultation and Support
With over two decades of experience, we have empowered 500+ companies to navigate the CDSCO licensing maze with confidence. From meticulous documentation preparation to pre-audit readiness, our services ensure:
- Tailored regulatory strategies for Class C oncology devices
- End-to-end application management on the CDSCO MD Online Portal
- Liaison with notified bodies and CDSCO inspectors
- Comprehensive training on compliance and quality management
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class C status via the Medical Device Classification guide.
- Prepare the Test License Application (MD13): Compile technical data and apply early to avoid delays.
- Select CDSCO-Approved Testing Labs: Choose from the official testing laboratories list.
- Develop or Update Master Files: Use our guides for Device and Plant Master Files.
- Implement Risk Management Practices: Document per ISO 14971 standards.
- Submit Application on CDSCO MD Online Portal: Monitor application status and respond swiftly to queries.
Embarking on the licensing journey with thorough preparation and expert guidance is key to timely approval of your Blood Photochemical Treatment Agent. Contact us today to leverage our proven expertise and streamline your CDSCO licensing process.
