CDSCO License for Brain manual brachytherapy applicator
Medical Device Information
Intended Use
An applicator specifically designed for brain radiotherapy. A single or module applicator designed to facilitate manual placement (puncture, placement under endoscopy, or placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in the brain.
Comprehensive CDSCO Licensing Guide for Brain Manual Brachytherapy Applicator (Class D Medical Device)
Introduction: Understanding the Brain Manual Brachytherapy Applicator and Its Regulatory Significance
The Brain Manual Brachytherapy Applicator is a specialized medical device designed to facilitate the precise manual placement of therapeutic radiation sources in the brain. Given its critical role in radiotherapy, this device falls under Risk Class D, the highest risk category as per CDSCO classification. This classification requires rigorous regulatory compliance to ensure patient safety and efficacy. Navigating the CDSCO licensing process for such a device can be complex, but with over 25 years of experience and having supported 500+ companies, we provide you with an expert roadmap to streamline your journey into the Indian market.
CDSCO Regulatory Framework for Brain Manual Brachytherapy Applicator
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Ministry of Health and Family Welfare. For Class D devices such as this brachytherapy applicator, the Central Licensing Authority is responsible for granting manufacturing and import licenses.
The device is notified under File No. 29/Misc./03/2020-DC (180) dated 6.8.2021, categorizing it firmly within invasive radiotherapy tools requiring the most stringent regulatory oversight.
Risk Classification and License Requirements for Class D Devices
- Risk Class: D (High Risk)
- Applicable License Type: MD9 Manufacturing License (Form MD7)
- Licensing Authority: Central Licensing Authority (CDSCO HQ)
Due to the high-risk nature, the application process involves detailed technical scrutiny, mandatory product testing, comprehensive documentation, and an on-site audit conducted by CDSCO inspectors.
For importers, the corresponding license is the MD15 Import License (Form MD14) issued by the Central Authority.
Manufacturing License Process (MD9) for Brain Manual Brachytherapy Applicator
- Test License Application (Form MD13): Before manufacturing license application, a test license is mandatory. Processing time is approximately 1.5-2 months.
- Product Testing: The device must be tested at CDSCO-approved testing laboratories (Testing Laboratories List) to verify compliance with essential principles.
- Document Preparation: Compile all technical and quality documents including Device Master File and Plant Master File.
- License Application Submission: Apply for the MD9 manufacturing license on the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: After document scrutiny, CDSCO conducts an on-site audit.
- Query Resolution: Address any observations or queries from CDSCO.
- License Grant: Final license issued on Form MD9 enabling manufacture.
Overall, the process typically spans 4-5 months.
Manufacturing License Documents Required for MD9
- Company Constitution and Incorporation Certificate
- Proof of Ownership/Lease of Manufacturing Premises
- Qualifications and Experience of Technical Staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF): Detailed device description, design, and manufacturing process (Device Master File Guide)
- Plant Master File: Manufacturing facility details, quality control processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with regulatory standards
- Risk Management File (per ISO 14971) documenting hazard analysis and mitigation strategies (Risk Management)
- Test Reports from approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (usually ISO 13485 certified)
Import License Process (MD15) for Brain Manual Brachytherapy Applicator
For companies planning to import this device, obtaining the MD15 Import License is mandatory. The process involves:
- Document Compilation: Manufacturing license of foreign manufacturer, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, DMF, PMF, Wholesale License, and Company Constitution.
- Application Submission: File Form MD14 on the CDSCO MD Online Portal.
- Review and Query Resolution: CDSCO reviews, raises queries if necessary.
- License Issuance: Granted on Form MD15.
The import license process typically takes 5-6 months.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate or Equivalent
- ISO 13485:2016 Certification
- CE Certificate or other regulatory approvals
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable in India)
- Company Constitution and Importer Authorization
Timeline and Processing Duration
| License Type | Process Duration | Key Steps |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Application, testing license issuance |
| MD9 Manufacturing | 4 - 5 months | Testing, audit, query resolution |
| MD15 Import | 5 - 6 months | Document review, query resolution |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | ₹50,000 | ₹1,000 |
| MD15 Import | Class D: ₹3,0000 | ₹1,500 |
Note: These are statutory fees payable via the CDSCO portal.
Common Challenges and Solutions in CDSCO Licensing for Class D Devices
- Extensive Documentation: Ensuring a comprehensive and compliant Device Master File and Plant Master File can be daunting. We recommend leveraging templates and expert consultation to avoid common pitfalls.
- Testing Delays: Testing at government-approved labs may cause bottlenecks. Early engagement and scheduling can mitigate this.
- Audit Readiness: CDSCO audits are stringent; pre-audit internal checks and robust QMS maintenance are critical.
- Query Management: Proactive and thorough responses to CDSCO queries expedite approvals.
Expert Consultation and Support
With our expertise guiding over 500 clients through the CDSCO licensing maze, we offer tailored support including:
- End-to-end document preparation
- Coordination with notified bodies and testing labs
- Pre-audit readiness assessments
- Regulatory strategy to optimize timelines
Our proactive approach ensures your Brain Manual Brachytherapy Applicator reaches the Indian market efficiently and compliantly.
Getting Started with Your CDSCO License Application for Brain Manual Brachytherapy Applicator
- Assess your device classification and identify applicable license (MD9 for manufacturing, MD15 for import).
- **Begin compiling essential documents focusing on DMF, PMF, QMS, and risk management.
- Apply for the Test License (Form MD13) via the CDSCO MD Online Portal.
- Schedule product testing at approved labs (Testing Laboratories).
- Once test results are satisfactory, submit your manufacturing license application (Form MD7) online.
- Prepare for and facilitate the CDSCO audit with all documentation readily accessible.
- Respond promptly to any CDSCO queries to avoid undue delays.
For importers, focus on obtaining the necessary foreign certifications and compile import license documents before applying via Form MD14.
Embarking on this process can be complex, but with the right expertise and preparation, your Brain Manual Brachytherapy Applicator can achieve CDSCO licensing and successfully enter the Indian healthcare market. Contact us to leverage our extensive experience and ensure a seamless regulatory journey.
For detailed guidance on MD9 licensing, refer to our comprehensive MD9 License Guide.
