CDSCO License for Applicator for eye manual brachytherapy
Medical Device Information
Intended Use
A template with a groove on the one side. The groove shows the position of the brachytherapy source that is manually, temporarily delivered to the eye surface. The other side is shielded.
Comprehensive Guide to CDSCO Licensing for Applicator for Eye Manual Brachytherapy (Class C Medical Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices like the Applicator for eye manual brachytherapy. This device, classified as Class C under the CDSCO framework, plays a critical role in radiotherapy by facilitating the manual, temporary delivery of brachytherapy sources to the eye surface with precise positioning and shielding. Given its high-risk nature and therapeutic application, obtaining the correct CDSCO license is both essential and mandatory to legally manufacture or import this device in India.
With over 25 years of expertise assisting 500+ companies to successfully secure CDSCO approvals, we provide a detailed, practical roadmap tailored specifically for this device type and risk classification.
CDSCO Regulatory Framework for Applicator for Eye Manual Brachytherapy
India’s Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR), 2017. The Applicator for eye manual brachytherapy falls under Class C due to its involvement in radiotherapy and potential impact on patient safety.
The regulatory framework mandates a manufacturing license (MD9) or an import license (MD15) granted by the Central Licensing Authority. The licensing process ensures compliance with quality, safety, and performance standards before the device reaches the Indian market.
To get started, manufacturers and importers must understand the classification, documentation, testing, and audit requirements stipulated by the CDSCO.
Risk Classification and License Requirements for Class C Devices
Class C devices are considered high-risk and therefore require rigorous evaluation. The Applicator for eye manual brachytherapy, given its radiotherapeutic use and direct interaction with sensitive ocular tissue, falls squarely in this category.
The licensing requirements for Class C devices include:
- Obtaining a Manufacturing License (MD9) using Application Form MD7 if manufacturing in India.
- Obtaining an Import License (MD15) using Application Form MD14 if importing.
Both pathways require thorough testing, documentation, and audits.
For more on device classification, refer to our Medical Device Classification guide.
Manufacturing License Process (MD9) for Applicator for Eye Manual Brachytherapy
Step 1: Obtain Test License (Form MD13)
Before applying for the MD9 license, manufacturers must obtain a test license which permits product testing from government-approved laboratories. This stage typically takes 1.5 to 2 months.
Step 2: Product Testing
The applicator must undergo rigorous testing for safety, biocompatibility, radiation shielding effectiveness, and performance parameters at CDSCO-recognized labs. You can find the list of testing laboratories here.
Step 3: Document Preparation
Prepare complete documentation including quality system files, Device Master File (DMF), Plant Master File (PMF), risk management documentation, and labeling details.
Step 4: Apply for Manufacturing License (Form MD7)
Submit the application via the CDSCO MD Online Portal. The application will be reviewed centrally.
Step 5: CDSCO Inspection and Audit
An inspection by CDSCO officials and audit by notified bodies will follow. For Class C devices, the notified body plays a key role in verifying compliance. Check the list of notified bodies authorized for audits.
Step 6: Resolution of Queries
Respond promptly and comprehensively to any queries raised during the review or audit process.
Step 7: Grant of Manufacturing License (Form MD9)
Once all requirements are met, the MD9 license is granted, authorizing manufacture of the device.
The entire process from test license to final MD9 license typically takes 4 to 5 months.
For detailed insights, our MD9 License Guide is a valuable resource.
Manufacturing License Documents Required for Class C Applicator
The documentation demands are comprehensive and must be meticulously prepared:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Personnel
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, manufacturing, and performance
- Plant Master File (PMF) describing manufacturing facilities
- Essential Principles Checklist for device compliance
- Risk Management File showing hazard identification and mitigation (Risk Management Guide)
- Test Reports from government-approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) documents (ISO 13485 compliant)
Preparation of DMF and PMF can be streamlined using our guides: Device Master File Guide and Plant Master File Guide.
Import License Process (MD15) for Class C Applicator
For importers intending to bring the Applicator for eye manual brachytherapy into India, the MD15 license is mandatory.
Step 1: Document Preparation
Assemble documents including your manufacturing license from the exporting country, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, wholesale license, and company constitution.
Step 2: Application Submission
File the application on the CDSCO MD Online Portal using Form MD14.
Step 3: Queries and Clarifications
Address any departmental queries promptly.
Step 4: License Grant
After review, the MD15 import license is granted.
The import license process typically takes 5 to 6 months, with no requirement for a test license.
For a comprehensive overview, see our Import License Guide.
Import License Documents Required
- Valid manufacturing license from exporting country
- Free Sale Certificate (FSC) issued by the country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license for distribution in India
- Company Constitution and incorporation documents
- Proof of ownership or lease of premises
Timeline and Processing Duration Summary
| License Type | Approximate Duration | Key Milestones |
|---|---|---|
| MD9 (Manufacturing) | 4-5 months | Test License (1.5-2 mo), Testing, Audit, Queries, License Grant |
| MD15 (Import) | 5-6 months | Document Preparation, Application, Queries, License Grant |
Understanding and planning for these timelines ensures smooth regulatory compliance without costly delays.
Government Fees and Cost Breakdown
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 (Class C Device) | Rs 50,000 | Rs 1,000 |
| MD15 (Import) | USD 3,000 | USD 1,500 |
Additional costs to budget for:
- Testing and certification fees
- Audit fees charged by notified bodies
- Consultant fees (if engaging expert support)
Transparent budgeting mitigates surprises and expedites approvals.
Common Challenges and Practical Solutions
Challenge 1: Delays in obtaining test reports due to limited notified labs.
Solution: Engage early with notified labs and plan testing schedules proactively.
Challenge 2: Insufficient or incomplete documentation causing application rejections.
Solution: Utilize expert consultancy to prepare and review DMF, PMF, and risk files.
Challenge 3: Audit non-conformities related to QMS or facility.
Solution: Conduct internal pre-audits and corrective measures before CDSCO inspection.
Challenge 4: Complex queries during application review.
Solution: Respond promptly with detailed evidence and clarifications.
Our extensive experience allows us to anticipate and mitigate these issues effectively.
Expert Consultation and Support
Partnering with a regulatory consultant who understands the nuances of CDSCO licensing for Class C devices can save significant time and resources. We provide:
- End-to-end assistance from test license application to final approval
- Document preparation and review services
- Coordination with notified bodies and testing labs
- Training for internal teams on regulatory compliance
Our track record of supporting 500+ companies underscores our commitment to your success.
Getting Started with Your CDSCO License Application for Applicator for Eye Manual Brachytherapy
- Assess your device classification and confirm Class C status.
- Initiate a gap analysis of your current documentation and QMS against CDSCO requirements.
- Engage a notified testing laboratory early for scheduling product tests.
- Prepare Device Master File and Plant Master File using standardized templates.
- Submit the test license application (Form MD13) via the CDSCO MD Online Portal.
- Plan your timelines realistically—allocate 4 to 5 months for manufacturing license or 5 to 6 months for import license.
- Consider expert consultancy to navigate audits and respond to queries effectively.
Taking these practical steps ensures your Applicator for eye manual brachytherapy complies with Indian regulatory standards and reaches patients safely and legally.
For personalized support, reach out to our regulatory experts with over 25 years of proven success in CDSCO licensing.
