CDSCO License for Anorectal brachytherapy system applicator, manual
Medical Device Information
Intended Use
A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the rectum and/or anus.
Introduction to Anorectal Brachytherapy System Applicator and Its Regulatory Significance
Anorectal brachytherapy system applicators, manual type, are specialized medical devices used in radiation therapy for treating cancers of the rectum and anus. Given their critical role in oncology treatments, these devices demand stringent regulatory oversight to ensure safety and efficacy. Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process in India is essential for manufacturers and importers aiming to market these devices within the country. With over 25 years of experience assisting 500+ companies, we provide detailed guidance tailored specifically for Class C devices like this applicator.
CDSCO Regulatory Framework for Anorectal Brachytherapy Applicator
The CDSCO, under the Ministry of Health and Family Welfare, governs medical device approvals in India. The regulatory framework categorizes devices based on risk and intended use, with oncology devices such as the anorectal brachytherapy applicator falling under higher scrutiny due to patient safety implications. The device is notified under File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022, mandating compliance with CDSCO regulations for Class C devices.
Risk Classification and License Requirements for Class C Devices
The anorectal brachytherapy applicator is classified as a Class C medical device, indicating moderate to high risk. Devices in this category require a manufacturing license via Form MD7 (MD9 license) granted by the Central Licensing Authority. Similarly, importers must obtain an import license using Form MD14 (MD15 license). These licenses ensure that the device meets essential safety, quality, and performance standards before entering the Indian market.
For comprehensive details on device classification, manufacturers can refer to our Medical Device Classification guide.
Manufacturing License Process (MD9) for Class C Anorectal Brachytherapy Applicator
The MD9 license process for manufacturing Class C devices is centralized and involves several key steps:
Test License Application (Form MD13): Initially, manufacturers must apply for a test license, permitting limited manufacturing for testing and validation. This stage typically takes 1.5 to 2 months.
Product Testing: The device must undergo testing in CDSCO-approved laboratories. For a list of such labs, consult the Testing Laboratories directory.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
Application Submission: Submit the manufacturing license application on Form MD7 via the CDSCO MD Online Portal.
Audit & Inspection: CDSCO officials conduct an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
Query Resolution & License Grant: Address any queries raised during audit or document review promptly to avoid delays. Upon satisfactory compliance, the MD9 license is granted.
The entire process usually spans 4 to 5 months.
For detailed procedural insights, our MD9 License Guide is an invaluable resource.
Manufacturing License Documents Required for MD9
Successfully securing an MD9 license requires meticulous preparation of the following documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Valid Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
- Plant Master File (PMF) describing facilities and equipment (Plant Master File Guide)
- Essential Principles Checklist confirming device compliance with Indian regulations
- Risk Management File demonstrating hazard identification and mitigation strategies (Risk Management Overview)
- Test Reports from CDSCO-approved laboratories
- Product Labels, Instructions for Use (IFU), and Packaging Details
- Quality Management System Documentation (preferably ISO 13485:2016 certified)
Preparing these documents accurately is critical to avoid time-consuming back-and-forth during the review process.
Import License Process (MD15) for Class C Oncology Devices
Importing anorectal brachytherapy applicators into India requires an MD15 license granted by the Central Licensing Authority. The process includes:
Document Compilation: Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
Application Submission: File the application using Form MD14 through the CDSCO MD Online Portal.
Review and Queries: Respond promptly to any clarifications requested by CDSCO officers.
License Issuance: Upon satisfactory evaluation, the MD15 import license is granted.
The import license process typically takes 5 to 6 months.
For an in-depth walkthrough, consider our Import License Guide.
Import License Documents Required for MD15
Key documents for MD15 application include:
- Valid Manufacturing License from the country of manufacture
- Free Sale Certificate or Certificate of Pharmaceutical Product (CPP)
- ISO 13485:2016 Certification
- CE Certificate or equivalent international certification
- Device and Plant Master Files
- Wholesale Drug License (if applicable)
- Company Incorporation Documents
Ensuring these documents are complete and compliant reduces processing delays.
Timeline and Processing Duration for Anorectal Brachytherapy Applicator Licensing
| License Type | Timeline |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Manufacturing License (MD9) | 4 – 5 months total (including test license, testing, audit) |
| Import License (MD15) | 5 – 6 months |
Timelines may vary based on query resolution efficiency, completeness of documentation, and audit scheduling.
Government Fees and Associated Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 (Manufacturing) | ₹50,000 | ₹1,000 |
| MD15 (Import) Class C | $3,000 per site | $1,500 per product |
Additional costs to consider include testing fees at government-approved labs, audit fees payable to notified bodies, and consultancy charges if external support is engaged.
Common Challenges and Practical Solutions
Incomplete Documentation: Missing or inconsistent information often prolongs approval. Solution: Use detailed checklists and cross-verify all documents before submission.
Audit Non-Compliance: Non-adherence to GMP or lack of trained personnel can lead to audit failures. Solution: Conduct internal mock audits and invest in staff training.
Delayed Testing Reports: Testing backlogs at government labs can stall the process. Solution: Engage with multiple approved labs early and submit samples promptly.
Query Resolution Delays: Slow response to departmental queries extends timelines. Solution: Designate a dedicated regulatory liaison to coordinate and respond efficiently.
Expert Consultation and Support
Given the complexity of CDSCO licensing for Class C oncology devices, expert guidance is invaluable. Our team has successfully navigated regulatory pathways for over 500 companies, helping them avoid pitfalls and expedite approvals. We assist with document preparation, audit readiness, liaison with CDSCO, and post-approval compliance.
Getting Started with Your CDSCO License Application for Anorectal Brachytherapy Applicator
Assess Your Device Classification: Confirm Class C status via official CDSCO notifications or our Medical Device Classification resource.
Initiate Test License (MD13) Application: Prepare necessary documents and submit your test license application on the CDSCO MD Online Portal.
Engage Approved Testing Laboratories: Coordinate with government-approved labs early to schedule product testing.
Compile Comprehensive Documentation: Utilize guides on Device Master File and Plant Master File preparation.
Prepare for Audit: Schedule a pre-audit assessment and ensure your manufacturing facility complies with regulatory standards.
Submit Manufacturing License Application (MD9): Once testing and document preparations are complete, file your application for the manufacturing license.
Plan Import License Application (MD15): Parallelly, importers should prepare documentation and apply accordingly.
Embarking on the CDSCO licensing journey with systematic planning and expert support ensures smoother approvals and timely market entry for your anorectal brachytherapy system applicator.
