CDSCO License for Applicator for pancreas remote after loading brachytherapy
Medical Device Information
Intended Use
A remote controlled brachytherapy applicator specifically designed for pancreatic radiation therapy. It is designed to be temporarily implanted in the pancreas. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites.
Introduction: Understanding the Applicator for Pancreas Remote After Loading Brachytherapy and Its Regulatory Significance
The applicator for pancreas remote after loading brachytherapy is a highly specialized Class C medical device designed to enable precise, computer-controlled placement and removal of therapeutic radiation sources in pancreatic cancer treatment. Given its critical role in radiotherapy, this device falls under stringent regulatory scrutiny by the Central Drugs Standard Control Organization (CDSCO) in India to ensure patient safety and efficacy.
Manufacturers and importers aiming to enter the Indian market must navigate the CDSCO licensing landscape carefully. With over 25 years of experience supporting 500+ companies, we provide comprehensive insights into obtaining the required MD9 manufacturing license and MD15 import license tailored specifically for this device class.
CDSCO Regulatory Framework for Radiotherapy Applicators
Under the Medical Device Rules, 2017, devices like the pancreas remote after loading brachytherapy applicator are tightly regulated. These devices are classified as Class C due to their invasive nature and potential high risk involved in radiation therapy. The regulatory framework demands rigorous compliance, including quality management systems, technical documentation, testing, and audits.
Risk Classification and License Requirements for Class C Devices
According to CDSCO’s medical device classification, Class C devices require a manufacturing license known as the MD9 license, which is granted by the Central Licensing Authority. Importers must obtain an MD15 import license, also issued centrally.
- Manufacturing License (MD9): Mandatory for domestic manufacturers of Class C devices.
- Import License (MD15): Required for importers bringing Class C devices into India.
Manufacturing License Process (MD9) for Class C Radiotherapy Applicators
The MD9 license process typically spans 4 to 5 months and involves several critical steps:
- Test License (MD13): Initial test license application to manufacture and test the device; takes approximately 1.5 to 2 months.
- Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to validate safety and performance. Refer to the list of approved testing laboratories.
- Documentation Preparation: Compile comprehensive technical files including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documentation.
- Application Submission: Apply via the CDSCO MD Online Portal, submitting Form MD7 for the MD9 license.
- Audit and Inspection: CDSCO inspectors conduct a thorough audit of manufacturing facilities and quality systems.
- Query Resolution: Address any deficiencies or queries raised during the audit.
- License Grant: Upon satisfactory compliance, the MD9 license is granted on Form MD9.
For detailed insights, consult our MD9 License Guide.
Manufacturing License Documents Required for the Applicator
For a Class C radiotherapy applicator, the following documents are essential:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Details of Technical Staff
- Fire Safety No-Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, and specifications (Device Master File Guide)
- Plant Master File outlining manufacturing processes and quality controls (Plant Master File Guide)
- Essential Principles Checklist demonstrating conformity with regulatory standards
- Risk Management File documenting hazard analysis and mitigation (Risk Management)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Class C Radiotherapy Applicators
Importers must apply for the MD15 license through the Central Licensing Authority. The process takes approximately 5 to 6 months and includes:
- Document Compilation: Prepare all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
- Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.
- Review and Queries: CDSCO reviews the application and may raise queries.
- License Grant: After satisfactory evaluation, the MD15 import license is issued.
Refer to our comprehensive Import License Guide for further details.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate demonstrating market approval abroad
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution and Incorporation Certificates
- Detailed Product Description and Intended Use
Timeline and Processing Duration
| License Type | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| MD9 Manufacturing License | 4 - 5 months (including test license and audit) |
| MD15 Import License | 5 - 6 months |
Planning ahead for these timelines is crucial for market entry strategies.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing License | ₹50,000 | ₹1,000 |
| MD15 Import License (Class C/D) | USD 3,000 per site | USD 1,500 per product |
Note: Fees are indicative and subject to change by CDSCO.
Common Challenges and Solutions
- Delayed Testing Results: Engage early with CDSCO-approved laboratories to schedule testing.
- Incomplete Documentation: Utilize comprehensive checklists and expert reviews to ensure document completeness.
- Audit Non-Compliance: Pre-audit internal assessments and training can mitigate deficiencies.
- Query Resolution Delays: Prompt and precise responses to CDSCO queries are essential to avoid process delays.
Expert Consultation and Support
Navigating the regulatory landscape for a high-risk device like the pancreas remote after loading brachytherapy applicator requires specialized expertise. Our team has successfully guided over 500 companies through the CDSCO licensing process, ensuring timely approvals and compliance. We offer tailored support including document preparation, audit readiness, and strategic regulatory planning.
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm the risk class as Class C using the Medical Device Classification resource.
- Prepare Documentation: Start compiling your Device Master File, Plant Master File, and Risk Management File.
- Apply for Test License (MD13): Submit your application on the CDSCO MD Online Portal to begin manufacturing and testing.
- Schedule Testing: Coordinate with CDSCO-approved testing laboratories.
- Plan for Audit: Select a notified body for your audit if required and prepare accordingly by reviewing the list of notified bodies.
- Submit MD9 License Application: Once testing and documentation are complete, apply for the MD9 manufacturing license.
- For Importers: Simultaneously prepare for the MD15 import license application with all required supporting documents.
Starting early and leveraging expert guidance can significantly streamline your path to market approval. Contact us to discuss your specific device and receive personalized regulatory strategies.
