CDSCO License for Radionuclide brachytherapy table
Medical Device Information
Intended Use
A programmable bed for electric radiotherapy to adjust the patient's posture and immobilize the patient for treatment that uses an after loading short-distance irradiation treatment apparatus that is operated manually or electrically.
Comprehensive Guide to CDSCO Licensing for Radionuclide Brachytherapy Tables (Class B)
As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in successfully obtaining CDSCO licenses, we understand the unique challenges manufacturers and importers face when entering the Indian medical device market. This guide focuses on the Radionuclide brachytherapy table, a Class B radiotherapy device, highlighting the regulatory prerequisites, timelines, costs, and practical steps to secure your CDSCO license efficiently.
Introduction: Understanding Your Medical Device and Its Regulatory Importance
The Radionuclide brachytherapy table is a programmable bed designed to adjust patient posture precisely during radiotherapy treatments. It immobilizes patients using an after-loading short-distance irradiation apparatus, operated either manually or electrically. Given its critical role in cancer treatment and exposure to radioactive sources, regulatory oversight under CDSCO (Central Drugs Standard Control Organization) ensures safety, efficacy, and quality.
This device falls under Class B (low moderate risk) as per CDSCO classification, requiring compliance with specific licensing procedures before manufacturing or import.
CDSCO Regulatory Framework for Radionuclide Brachytherapy Tables
India regulates medical devices through the Medical Device Rules (MDR) 2017, administered by CDSCO. For Class B devices like the Radionuclide brachytherapy table, the MD5 Manufacturing License granted by the State Licensing Authority is mandatory for domestic production. Importers must secure the MD15 Import License through the Central Licensing Authority.
The regulatory framework demands:
- Compliance with Essential Principles of Safety and Performance
- Valid Device Master File (DMF) and Plant Master File (PMF)
- Product testing from government-approved laboratories
- Quality Management System adherence (ISO 13485:2016 recommended)
Risk Classification and License Requirements
The Radionuclide brachytherapy table is classified as a Class B device due to its moderate risk profile involving radiation exposure and patient immobilization. According to CDSCO:
| License Type | Authority | Processing Time | Fees |
|---|---|---|---|
| MD5 (Manufacturing License) | State Licensing Authority | 3-4 months | Rs 5000 + Rs 500 per product |
| MD15 (Import License) | Central Licensing Authority | 5-6 months | Varies by class (Class B: Rs 1,50,000 + Rs 75,000 per product approx.) |
Manufacturers require the MD5 license, while importers must obtain the MD15 license.
Manufacturing License Process (MD5) for Radionuclide Brachytherapy Tables
The MD5 license application for Class B devices involves a multi-step process:
- Test License (Form MD13): Apply for a test license, taking approximately 1.5-2 months, allowing you to manufacture prototypes or samples for testing.
- Product Testing: Submit the device for testing at a CDSCO-approved laboratory. You can find the list of testing laboratories here.
- Document Preparation: Compile all necessary documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, test reports, and QMS documents.
- License Application (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
- Audit by Notified Body: Coordinate with a notified body for a plant and quality system audit. Reference the list of notified bodies to select an approved auditor.
- Query Resolution: Address any queries from the licensing authority or the notified body promptly.
- Grant of License (Form MD5): Upon satisfactory review and audit, CDSCO will issue your MD5 manufacturing license.
Manufacturing License Documents Required
Accurate and comprehensive documentation is critical. For your Radionuclide brachytherapy table license, prepare the following:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification Certificates of Technical Personnel
- Fire NOC and Pollution Control NOC
- Device Master File (Detailed design, specifications, risk analysis) – see our detailed Device Master File guide
- Plant Master File (Manufacturing process, equipment, quality controls) – learn more in our Plant Master File guide
- Essential Principles Checklist Compliance
- Risk Management File demonstrating compliance with ISO 14971 – explore Risk Management best practices
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System documentation (preferably ISO 13485:2016 certified)
Import License Process (MD15) for Radionuclide Brachytherapy Tables
If you plan to import this device, the MD15 license is mandatory. The process is as follows:
- Document Preparation: Collate required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), DMF, PMF, and wholesale license.
- Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
- Queries and Clarifications: Respond promptly to any departmental queries.
- License Grant: Upon approval, CDSCO issues the MD15 import license.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
- Proof of compliance with Indian regulations
Timeline and Processing Duration
| License Type | Step | Duration |
|---|---|---|
| MD5 Manufacturing | Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 month | |
| Document preparation | 2 - 3 weeks | |
| Application & Audit | 1 - 1.5 months | |
| Total | 3 - 4 months | |
| MD15 Import License | Application & Review | 5 - 6 months |
Government Fees and Costs
- MD5 License: Rs 5,000 per application + Rs 500 per product
- MD15 Import License (Class B): Approx Rs 1,50,000 per site + Rs 75,000 per product
These fees exclude costs for product testing, notified body audits, and consultancy services.
Common Challenges and Solutions
- Delayed Testing Reports: Engage early with CDSCO-approved labs to schedule testing promptly.
- Incomplete Documentation: Use standardized templates for DMF and PMF to avoid rejections.
- Audit Non-compliance: Conduct a pre-audit internal review to ensure QMS and manufacturing processes meet CDSCO requirements.
- Query Management: Prepare a dedicated team to respond swiftly to CDSCO or notified body questions.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our consulting team has guided over 500 clients through the entire process for radiotherapy devices, ensuring precision in documentation, timely testing, and audit readiness. We assist with:
- Comprehensive document preparation
- Scheduling and managing testing & audits
- Liaison with regulatory authorities
- Post-approval compliance and renewals
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your Radionuclide brachytherapy table as Class B using CDSCO classification tools.
- Initiate Test License Application: Apply for the test license (MD13) through the CDSCO MD Online Portal.
- Engage Testing Laboratories Early: Book slots with approved labs to avoid delays.
- Prepare Essential Documentation: Begin compiling your Device and Plant Master Files, QMS, and risk management files.
- Plan for Notified Body Audit: Select a notified body from the official list and schedule your audit.
- Monitor Application Progress: Use the online portal to track your application and respond quickly to queries.
By following these actionable steps and leveraging expert guidance, manufacturers and importers of Radionuclide brachytherapy tables can achieve timely CDSCO licensing and successfully enter the Indian market.
For personalized assistance tailored to your specific product and business needs, contact our regulatory consulting team today.
