CDSCO License for Fixed-aperture therapeutic x-ray system collimator
Medical Device Information
Intended Use
A non-automated, x-ray beam-limiting device that is a component of a therapeutic x-ray system and whose opening size/length/shutter assembly is fixed. It is used in radiation therapy applications to limit the effects of scattered radiation and to protect the patient by limiting or eliminating exposure to non-target body areas during treatment. This device is specifically designed for use with an x-ray simulation or therapeutic x-ray system.
Comprehensive Guide to CDSCO Licensing for Fixed-Aperture Therapeutic X-Ray System Collimator (Class C)
As specialists with over 25 years of experience and having successfully assisted more than 500 medical device companies, we understand the intricacies involved in obtaining CDSCO licensing for specialized devices such as the Fixed-aperture therapeutic x-ray system collimator. This device, classified as Class C under the Indian regulatory framework, plays a crucial role in oncology by precisely limiting x-ray exposure during radiation therapy.
Understanding the Device and Its Regulatory Importance
The Fixed-aperture therapeutic x-ray system collimator is a non-automated beam-limiting device designed specifically for therapeutic x-ray systems. Its primary function is to confine the radiation beam to the target area, thereby minimizing scattered radiation and protecting patients from unnecessary exposure. Given its critical role in radiation therapy and potential safety implications, it falls under Class C risk, mandating stringent regulatory oversight by CDSCO.
CDSCO Regulatory Framework for Fixed-Aperture Therapeutic X-Ray System Collimator
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules, 2017. For Class C devices like this collimator, the regulatory pathway involves obtaining an MD9 manufacturing license from the Central Licensing Authority, following a well-defined process including testing, documentation, and audits.
Risk Classification and License Requirements
- Risk Class: C
- Applicable License: MD9 (Manufacturing License) for Class C & D devices
- Governing Authority: CDSCO Central Licensing Authority
Given the device’s classification, manufacturers must comply with comprehensive quality and safety requirements, including mandatory testing and audits by CDSCO inspectors.
Manufacturing License Process (MD9)
The MD9 license process typically spans 4 to 5 months and comprises these key stages:
- Test License (Form MD13): Initially, manufacturers must obtain a test license to commence product testing. This step usually takes about 1.5 to 2 months.
- Product Testing: Testing must be conducted at CDSCO-approved government laboratories to verify device safety and performance. You can find the list of approved testing laboratories here.
- Documentation Preparation: Preparing detailed technical and quality documentation, including Device Master File and Plant Master File.
- License Application Submission (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
- CDSCO Inspection and Audit: CDSCO inspectors will conduct an audit of the manufacturing facility and quality systems.
- Resolution of Queries: Address any queries raised by the department or auditors promptly.
- Grant of License (Form MD9): Upon satisfactory compliance, the MD9 license is granted.
For a detailed walkthrough, our MD9 License Guide offers practical insights.
Manufacturing License Documents Required
Successful MD9 license applications require a comprehensive set of documents, including but not limited to:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Documents
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF): Detailed device description, design, and specifications. Refer to our Device Master File guide for best practices.
- Plant Master File (PMF): Manufacturing processes and quality control systems. See our Plant Master File Guide for comprehensive details.
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File demonstrating hazard analysis and mitigation strategies (aligned with ISO 14971). Explore our Risk Management resource for implementation.
- Product Test Reports from CDSCO-approved laboratories
- Product Labeling and Instructions for Use (IFU)
- Quality Management System Documents (preferably ISO 13485:2016 certified)
Import License Process (MD15)
For companies importing this device into India, obtaining the MD15 import license from CDSCO Central Licensing Authority is mandatory. The process generally takes 5 to 6 months and includes:
- Preparation of import-specific documentation
- Submission of application via CDSCO MD Online Portal
- Queries resolution
- Grant of import license on Form MD15
Key import license documents include:
- Valid Manufacturing License (MD9) from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent international certification
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution
More detailed information is available in our Import License Guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Documentation & Application | 1 month |
| CDSCO Inspection & Audit | 1 month |
| Query Resolution & Final Approval | 1 month |
Total: Approximately 4-5 months for MD9 manufacturing license.
Government Fees and Costs
- MD9 Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product
Additional costs include testing fees at government-approved labs and audit fees if any (usually borne by the applicant).
Common Challenges and Solutions
Challenge: Delays in test report acquisition due to limited capacity at approved labs.
Solution: Early scheduling of testing and coordination with labs can mitigate delays.
Challenge: Incomplete or inconsistent documentation leading to query cycles.
Solution: Engage expert consultants to perform thorough document gap analysis prior to submission.
Challenge: Audit non-compliance due to inadequate QMS or facility standards.
Solution: Implement ISO 13485:2016 standards and pre-audit mock inspections.
Expert Consultation and Support
Given the complexity of the Class C licensing process, our expert regulatory consultants provide end-to-end support, including:
- Regulatory strategy and classification advice
- Compilation and review of technical documentation
- Coordination with notified bodies and testing labs
- Application submission and follow-up
- Post-license compliance and renewal guidance
Our proven track record with over 500 successful clients positions us as a trusted partner for your CDSCO licensing journey.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm Class C status using the Medical Device Classification resource.
- Initiate Test License Application: Prepare initial documentation and apply for the MD13 test license via the CDSCO MD Online Portal.
- Plan Product Testing: Engage with CDSCO-approved labs early to schedule testing.
- Develop Required Documentation: Assemble your Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Submit MD9 License Application: Once test reports and documents are ready, submit your Form MD7 application.
- Prepare for Audit: Conduct internal audits and readiness assessments to ensure compliance.
- Respond Promptly to Queries: Address any departmental or audit observations swiftly.
Embarking on the CDSCO licensing pathway for your Fixed-aperture therapeutic x-ray system collimator need not be daunting. With meticulous preparation and expert guidance, you can secure your MD9 manufacturing license efficiently and confidently, enabling your device to reach patients in India responsibly and compliantly.
